This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003) (NCT03645395), a non-randomized phase 2 study. The primary outcome is Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03645395 |
| Phase | Phase 2 |
| Condition | Non-hodgkin Lymphoma |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Molecular Templates, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsed or refractory B-cell non-Hodgkin lymphoma. The safety population included participants who received at least one dose of MT-3724 or lenalidomide. The registry record reports 9 enrolled participants.
Intervention
MT-3724 given in combination with lenalidomide. Part 1 included dose regimens of 10 mcg/kg, 20 mcg/kg, and 25 mcg/kg. The descriptions specify intravenous dosing on schedules that varied by dose and treatment cycle.
Comparator
There was no randomized control group. The study used sequential dose groups, so comparisons among the listed groups are not like-for-like randomized comparisons. Part 2 was not initiated.
Primary question
The primary outcome counted participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicity, assessed up to 1 year. The study also listed pharmacokinetic, pharmacodynamic, immunogenicity, and tumor-response outcomes.
The central clinical question was whether MT-3724, when combined with lenalidomide, could be evaluated for safety and tolerability in participants with relapsed or refractory B-cell non-Hodgkin lymphoma. The official title identifies maximum tolerated dose as part of the safety and tolerability investigation. A dose-limiting toxicity was defined as a treatment-emergent adverse event after the start of infusion in cycle 1 of Part 1 that was at least possibly related to study drug, as determined by the sponsor after consultation with investigators.
The study was open-label and non-randomized. Participants were assigned through sequential dose regimens rather than randomized to a treatment or control condition. The record describes three Part 1 groups at 10 mcg/kg, 25 mcg/kg, and 20 mcg/kg with lenalidomide. It also describes Part 2 regimens, but Part 2 was not initiated because the sponsor decided to terminate the trial. The record does not report a control treatment or a randomized comparison.
Safety was the primary focus, but the registry also lists objective response rate, duration of response, progression-free survival, overall survival, plasma concentrations of MT-3724, change from baseline in B-cell count, and anti-drug and neutralizing antibody outcomes. Result values for those secondary outcomes are not reported in the registry record. Accordingly, the available information supports a description of the study question and posted adverse-event counts, not an estimate of comparative efficacy.
3. Trial Design
This was a Phase 2a, open-label, non-randomized, sequential study of MT-3724 in combination with lenalidomide for relapsed or refractory B-cell non-Hodgkin lymphoma. The registry record lists an enrollment of 9 and identifies the study status as terminated. The listed study start was 2019-04-08, and the primary completion date was 2021-03-10. Part 2 was not initiated because of the sponsor’s decision to terminate the trial.
Part 1 included three dose groups: MT-3724 10 mcg/kg with lenalidomide, MT-3724 25 mcg/kg with lenalidomide, and MT-3724 20 mcg/kg with lenalidomide. For the 10 mcg/kg and the 20 and 25 mcg/kg three-times-a-week regimens, the description specifies intravenous doses on Days 1, 3, 5, 8, 10, and 12 of each 28-day cycle, with a different weekly schedule described if treatment continued beyond Cycle 2. The record also describes 25 mcg/kg twice a week and 50 mcg/kg regimens for Part 2, but that part did not begin. The exact sequence in which participants entered the Part 1 groups is not reported in the registry record.
Because allocation was non-randomized and masking was absent, the dose groups should be read as sequential study cohorts rather than as balanced treatment arms in a controlled comparison. Group differences could reflect factors other than dose, and the record does not establish that the groups were comparable at baseline. A placebo or active comparator is not listed.
The primary outcome was the number of participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicity, with a timeframe of up to 1 year. The safety population included people who received at least one dose of either study drug. The registry record lists 11 outcome measures overall, but does not report a detailed statistical analysis plan, an enrollment target rationale, or the method used to summarize each outcome. Those elements are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Total 9 participants were enrolled in the study. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Part 1 (Up to 6 Months)
| Stage | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN |
|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 0 |
| COMPLETED | 1 | 0 | 0 | 0 |
| NOT COMPLETED | 2 | 3 | 3 | 0 |
Reasons for not completing this period:
| Reason | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN |
|---|---|---|---|---|
| Adverse Event | 1 | 0 | 0 | 0 |
| Disease Progression | 0 | 1 | 0 | 0 |
| Withdrawal by Subject | 0 | 0 | 1 | 0 |
| Sponsor's decision to close the trial | 1 | 2 | 2 | 0 |
Part 2 (Up to 6 Months)
| Stage | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN |
|---|---|---|---|---|
| STARTED | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Population included participants who received at least one dose of any study drug (either MT-3724, or lenalidomide). Part 2 was not initiated due to Sponsor's decision to terminate the trial.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Part 2 was not initiated due to Sponsor's decision to terminate the trial.
| Characteristic | Unit | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 3 | 0 | 9 | |
| Age, Continuous | Years | 62.3 (SD 8.33) | 61.3 (SD 8.33) | 71.0 (SD 12.77) | — | 64.9 (SD 9.83) |
| Sex: Female, Male: Female | Participants | 3 | 1 | 2 | — | 6 |
| Sex: Female, Male: Male | Participants | 0 | 2 | 1 | — | 3 |
| Race/Ethnicity, Customized: Black or African American | Participants | 1 | 1 | 1 | — | 3 |
| Race/Ethnicity, Customized: White | Participants | 2 | 2 | 1 | — | 5 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 0 | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity, measured over Up to 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicity. Its stated timeframe is up to 1 year. A treatment-emergent adverse event is an untoward medical occurrence or clinical investigation in a participant receiving a pharmaceutical product; the event does not have to be causally related to the experimental treatment. A serious adverse event is defined by outcomes such as being fatal or life-threatening, causing or extending hospitalization, resulting in permanent disability, or involving a congenital abnormality or birth defect. The registry definition also allows other important medical events to be considered serious on medical judgment.
Dose-limiting toxicity has a narrower definition: it must be a treatment-emergent adverse event occurring after infusion begins in cycle 1 of Part 1 and considered at least possibly related to study drug by the sponsor after consultation with investigators. This definition distinguishes general safety events from events relevant to dose escalation or tolerability assessment.
Counting participants with events is useful in an early-phase safety investigation because it describes how many people in each group experienced an event, rather than treating multiple events in one participant as independent observations. It can provide a direct descriptive account of event occurrence in the observed participants. However, these counts alone do not establish causation, quantify risk relative to an untreated group, or provide a precise estimate for a wider population. The registry record does not provide a separate numerical result for dose-limiting toxicity in the available outcome information. The posted adverse-event group counts therefore should not be assumed to represent a complete numerical report of every component of the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record reports 3 participants at risk in each of the three Part 1 groups represented in the adverse-event data. In each group, 1 participant was reported with a serious adverse event, and 3 participants were reported with other adverse events. No deaths were reported in those groups. These are small group counts and are descriptive; they do not support a stable estimate of event frequency beyond the participants observed.
The serious adverse-event terms listed include atrial fibrillation, congestive heart failure, bacteraemia, pneumonia, capillary leak syndrome, and neutropenia. Each term is accompanied by 33.3% in the registry record. The record does not make the denominator for these term-specific percentages clear in the information available, so the percentages should be read as reported rather than used to infer participant-level rates or event counts. The event terms identify reported categories but do not establish that the study drugs caused them.
There was no randomized control group, and allocation was non-randomized. Therefore, differences across dose groups cannot be interpreted as causal dose effects. The cohorts are small, and no basis for adjusting for participant characteristics is reported. A lack of reported events in any category would not, by itself, rule out that event in a broader population. Conversely, an event occurring during treatment does not demonstrate that the treatment caused it, especially because the registry definition of a treatment-emergent event does not require a causal relationship.
The primary outcome concerns safety, while the registry also lists measures of tumor response, survival, pharmacokinetics, pharmacodynamics, and immunogenicity. Numerical results for those secondary outcomes are not reported in the registry record. The record lists no analysis entries. Thus, efficacy cannot be judged from the listed outcomes alone, and no treatment-effect estimate or uncertainty interval for efficacy is available in the record.
The study ended without initiating Part 2. This limits what can be concluded about the planned higher-dose regimens and any intended continuation of the dose investigation. The posted data describe the observed safety counts for the Part 1 groups; they do not provide a controlled comparison, a reliable estimate of uncommon harms, or evidence for how outcomes would differ under another treatment. Any broader interpretation should reflect the small enrolled sample, the sequential non-randomized design, and the lack of reported outcome analyses beyond the posted counts.
9. Statistical Methods Explained
The design determines what statistical conclusions are available. This study was open-label, non-randomized, and sequential. There was no randomized allocation to balance known and unknown participant characteristics between groups, and no masking to reduce awareness of treatment assignment. The dose groups are therefore descriptive cohorts, not randomized arms in a comparative experiment. General statistical principle: randomization supports causal comparisons by reducing systematic differences between groups, while non-randomized comparisons may be confounded by participant characteristics, timing, or other factors. The registry record does not report an adjustment strategy for such differences.
What does a participant count tell us?
The primary outcome is expressed as a number of participants with events. A count is directly interpretable as the number of observed people meeting an outcome definition, but its meaning depends on the number at risk and the follow-up period. Here, the registry gives three participants at risk in each represented Part 1 group and a primary timeframe of up to 1 year. With such small cohorts, a single participant changes the descriptive picture substantially. The counts should not be mistaken for precise population rates.
General statistical principle: a confidence interval describes a range of values compatible with observed data under a stated statistical model. Wider intervals indicate less precision. The registry record does not report confidence intervals for these adverse-event counts, and none should be inferred from the counts alone. The record also does not report a model for estimating adjusted event probabilities.
Why does the design matter for comparisons?
Non-randomized sequential cohorts do not guarantee comparable groups. Differences in adverse events across dose groups could reflect dose, but could also reflect differences in the people enrolled, their clinical circumstances, or the sequence of recruitment. Open-label conduct may also affect event recognition or reporting. These are general considerations for unmasked, non-randomized studies; the registry record does not indicate that any particular source of bias occurred. Because no randomized control group is listed, the data cannot isolate the effect of MT-3724 plus lenalidomide from other explanations.
The study is described as Phase 2a and includes evaluation of maximum tolerated dose. A dose-limiting toxicity definition is reported, focused on qualifying events during cycle 1 of Part 1. However, the detailed dose-escalation rules, stopping rules, decision algorithm, and method for determining maximum tolerated dose are not reported in the registry record. It would therefore be inappropriate to infer those procedures from the sequential design alone.
What is the role of the listed analysis information?
The registry record lists no analysis entries. It does not report a statistical analysis plan specifying hypothesis tests, estimands, covariate adjustment, confidence-interval methods, or handling of repeated events. The outcome descriptions identify measures of safety, pharmacokinetics, pharmacodynamics, immunogenicity, response, and survival, but result values for the secondary outcomes are not reported. The absence of an analysis entry is not evidence that no analyses were conducted outside the registry; it means the record does not document them.
The record includes assumptions for a separate planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Such calculations are hypothetical planning scenarios. General statistical principle: sample-size calculations ask how many participants might be needed under chosen assumptions to detect an effect with specified operating characteristics. They do not describe the probability that this completed study found a true effect, and they are not observed power. The record’s planning assumptions should not be mistaken for the original trial’s design justification; that justification is not reported in the registry record.
For binary outcomes, a planning calculation expressed as participants per arm is distinct from the observed number of participants with events. For time-to-event outcomes, a calculation based on total events is distinct from the number of participants enrolled. Those are general differences in the quantities used for planning. No numerical planning results are stated in the record information available for this interpretation, so no sample-size requirement can be inferred from the assumptions alone.
Why can over-dispersion matter?
General statistical principle: over-dispersion occurs when observed variability exceeds what a chosen statistical model expects. It can make standard errors too small and confidence intervals too narrow if ignored. It is most relevant when models are used for counts, clustered observations, or repeated measurements. The registry record does not report an over-dispersion assessment or a count model, and the primary outcome is a participant count rather than a reported repeated-event model. Thus, over-dispersion should not be invoked as an explanation for these posted counts.
Overall, the record supports basic descriptive interpretation: counts of affected participants within small, non-randomized cohorts. It does not document inferential methods that would justify adjusted comparisons, formal testing, or precision claims. The distinction between descriptive results and model-based inference is particularly important when the groups are small and the study did not include a randomized comparator.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, spanning safety, plasma concentrations, B-cell counts, antibody responses, objective response, duration of response, progression-free survival, and overall survival. Considering many outcomes can raise a multiplicity issue: when multiple hypotheses are tested, the chance of at least one apparently notable result can increase. General statistical principle: a prespecified testing hierarchy or multiplicity adjustment can control particular error rates. The registry record does not report a multiplicity strategy, a testing hierarchy, or a statistical analysis plan. No formal testing results are listed, so the record does not permit assessment of how multiplicity was handled.
Missing-data methods are also not reported in the registry record. The safety population is defined as participants who received at least one dose of either MT-3724 or lenalidomide, but the record does not describe how participants with incomplete follow-up, missing assessments, or treatment discontinuation were handled for each outcome. It does not state whether any imputation was used or how censoring was addressed for time-to-event outcomes. These details matter because missingness can affect estimates, especially when follow-up is incomplete or related to health status.
The record says Part 2 was not initiated because the sponsor decided to terminate the trial. It does not report a broader population-analysis plan or outcome-specific analysis populations beyond the safety-population definition. Part 2 therefore contributes no reported participants to the described adverse-event groups. Numerical findings for the listed efficacy, pharmacokinetic, pharmacodynamic, and immunogenicity outcomes are not reported in the registry record. Without outcome-specific denominators, missing-data rules, and analysis details, those outcomes cannot be reconstructed or interpreted statistically from their titles alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part 1: MT-3724 10 mcg/Kg-LEN | 1 | 3 | 33.3% |
| Part 1: MT-3724 25 mcg/Kg-LEN | 1 | 3 | 33.3% |
| Part 1: MT-3724 20 mcg/Kg-LEN | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: MT-3724 10 mcg/Kg-LEN | 0 of 3 |
| Part 1: MT-3724 25 mcg/Kg-LEN | 0 of 3 |
| Part 1: MT-3724 20 mcg/Kg-LEN | 0 of 3 |
| Part 2: MT-3724 50mcg/Kg-LEN | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part 1: MT-3724 10 mcg/Kg-LEN | 3 of 3 |
| Part 1: MT-3724 25 mcg/Kg-LEN | 3 of 3 |
| Part 1: MT-3724 20 mcg/Kg-LEN | 3 of 3 |
| Part 2: MT-3724 50mcg/Kg-LEN | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 1 of 3 | 0 of 3 | 0 of 3 | 0 of 0 |
| Congestive heart failure | Cardiac disorders | 1 of 3 | 0 of 3 | 0 of 3 | 0 of 0 |
| Bacteraemia | Infections and infestations | 1 of 3 | 0 of 3 | 0 of 3 | 0 of 0 |
| Pneumonia | Infections and infestations | 0 of 3 | 0 of 3 | 1 of 3 | 0 of 0 |
| Capillary leak syndrome | Vascular disorders | 0 of 3 | 1 of 3 | 0 of 3 | 0 of 0 |
| Neutropenia | Blood and lymphatic system disorders | 0 of 3 | 1 of 3 | 0 of 3 | 0 of 0 |
| Anaemia | Blood and lymphatic system disorders | 0 of 3 | 1 of 3 | 0 of 3 | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: MT-3724 10 mcg/Kg-LEN | Part 1: MT-3724 25 mcg/Kg-LEN | Part 1: MT-3724 20 mcg/Kg-LEN | Part 2: MT-3724 50mcg/Kg-LEN |
|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 2 of 3 | 2 of 3 | 0 of 0 |
| Hypokalaemia | Metabolism and nutrition disorders | 2 of 3 | 1 of 3 | 2 of 3 | 0 of 0 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 3 | 3 of 3 | 1 of 3 | 0 of 0 |
| Oedema peripheral | General disorders | 0 of 3 | 3 of 3 | 1 of 3 | 0 of 0 |
| Constipation | Gastrointestinal disorders | 2 of 3 | 0 of 3 | 1 of 3 | 0 of 0 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 0 of 3 | 2 of 3 | 1 of 3 | 0 of 0 |
| Proteinuria | Renal and urinary disorders | 2 of 3 | 1 of 3 | 0 of 3 | 0 of 0 |
| Pyrexia | General disorders | 0 of 3 | 1 of 3 | 2 of 3 | 0 of 0 |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 0 of 3 | 2 of 3 | 0 of 3 | 0 of 0 |
| Anaemia | Blood and lymphatic system disorders | 0 of 3 | 1 of 3 | 1 of 3 | 0 of 0 |
Serious events with the highest arm-level rate: atrial fibrillation (33.3%), congestive heart failure (33.3%), bacteraemia (33.3%), pneumonia (33.3%), capillary leak syndrome (33.3%).
For each represented Part 1 group, the registry reports 3 participants at risk for serious adverse events and 1 participant affected. It also reports 3 participants at risk for other adverse events and 3 affected. Deaths are recorded as 0 in each of these groups. These figures describe the participants counted in the registry; they are not estimates from a larger population.
The serious adverse-event list names atrial fibrillation, congestive heart failure, bacteraemia, pneumonia, capillary leak syndrome, and neutropenia, each with a reported value of 33.3%. The denominator and whether terms represent unique participants or events are not specified in the record information available. The percentages should not be converted into counts or treated as mutually exclusive categories without that information.
Seriousness and causality are separate concepts. The registry definition classifies an event as serious by its consequences or clinical importance, while a treatment-emergent event does not necessarily have to be caused by study treatment. The listed events therefore do not, on their own, establish drug-related harm. The study’s definition of dose-limiting toxicity additionally requires timing in cycle 1 of Part 1 and an assessment of at least possible relation to study drug. The posted group counts should not be treated as a substitute for a complete causal assessment or a detailed account of each event.
12. What the Result Does, and Does Not, Mean
The posted safety results show that, in each of the three Part 1 groups, 1 of 3 participants was reported with a serious adverse event and all 3 were reported with other adverse events. No deaths were reported in those groups. The serious-event terms listed in the record include several distinct clinical categories. These findings describe what was recorded among the participants in the study; the small group sizes mean the counts provide limited precision about how often such events might occur in a broader population.
The results do not establish that MT-3724 or lenalidomide caused any specific event. Treatment-emergent status indicates that an event occurred during the relevant treatment period, not necessarily that treatment caused it. The record’s serious adverse-event definition is based on severity criteria, and the dose-limiting toxicity definition adds timing and relatedness requirements. No separate numerical dose-limiting toxicity result is included in the available information.
The non-randomized design does not permit a controlled comparison of the dose groups. It does not establish that a difference among groups is due to dose, and it does not provide a comparison with standard care, placebo, or no treatment. The sequential structure and open-label conduct should be considered when interpreting the counts.
The registry lists efficacy and other secondary outcomes, including objective response rate and survival measures, but their numerical results are not reported in the registry record. As a result, the listed safety findings cannot answer whether the combination changed tumor response or survival. Nor do the absence of reported efficacy results or the termination of Part 2 establish any particular efficacy conclusion. The record supports a limited descriptive account of safety in the observed Part 1 participants, not a general treatment-effect conclusion.
13. Why This Trial Matters Statistically
This study illustrates why trial design and outcome reporting matter as much as the headline event counts. A Phase 2a investigation can focus on safety and tolerability while also listing exploratory pharmacokinetic, pharmacodynamic, immunogenicity, and tumor-response measures. Here, the primary outcome concerns treatment-emergent adverse events, serious adverse events, and dose-limiting toxicity, while the record also identifies outcomes that could describe drug exposure, biological changes, response, and survival.
The statistical interpretation is constrained by the non-randomized, sequential design. Without randomized allocation, dose groups are not guaranteed to be comparable, and observed group differences cannot be cleanly attributed to dose. The absence of masking is another important design feature when event identification or assessment may involve judgment. These limitations do not make descriptive counts meaningless, but they define what those counts can answer.
Small groups make uncertainty especially important. A count such as 1 participant with a serious adverse event in a group of 3 is an observation in that cohort, not a precise estimate of the rate in a wider population. The registry record does not provide confidence intervals or a formal comparative analysis. Readers therefore need to separate the observed counts from broader claims about safety.
The trial’s termination and the non-initiation of Part 2 also affect the scope of evidence. The available record does not describe results for the planned Part 2 regimens or numerical results for the listed secondary outcomes. This makes transparent reporting of study status, analysis methods, denominators, and missing-data handling especially useful. The record offers a clear setting for learning how to interpret descriptive safety data without overstating what a small, uncontrolled study can establish.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The reported safety groups are small, with 3 participants at risk in each of the three Part 1 groups. Such counts cannot provide high precision about event occurrence beyond the enrolled participants. The registry record does not report confidence intervals or another measure of uncertainty for the adverse-event counts.
Allocation was non-randomized and the study was open-label. The groups may differ for reasons unrelated to dose, and the design does not include a randomized control group. Consequently, comparisons among groups cannot establish causal dose effects or separate treatment effects from other explanations. The registry record does not report adjustment for baseline differences.
Part 2 was not initiated because the sponsor decided to terminate the trial. The available safety groups therefore do not describe outcomes for the Part 2 regimens. The record does not report a reason beyond the sponsor’s decision, and no further explanation should be inferred.
The registry lists secondary outcomes, including response, duration of response, progression-free survival, overall survival, pharmacokinetics, pharmacodynamics, and immunogenicity, but their numerical results are not reported in the registry record. It also does not report detailed analysis methods, missing-data handling, a multiplicity strategy, or a sample-size justification. The term-specific serious adverse-event percentages are listed without enough denominator detail to interpret them as participant-level risks. Together, these gaps limit assessment of precision, comparative effects, and the completeness of outcome reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003) — NCT03645395.
- Registry record last updated 2022-08-16; status last verified 2022-07.
- Results first posted 2022-08-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03645395 is a Phase 2a, open-label, non-randomized, sequential study of MT-3724 with lenalidomide in participants with relapsed or refractory B-cell non-Hodgkin lymphoma. The registry record lists 9 enrolled participants and a terminated status. Part 1 included MT-3724 dose groups of 10 mcg/kg, 25 mcg/kg, and 20 mcg/kg with lenalidomide. Part 2 was not initiated because of the sponsor’s decision to terminate the trial.
The primary outcome counted participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicity over up to 1 year. For each represented Part 1 group, the record reports 1 participant with a serious adverse event and 3 with other adverse events, among 3 at risk; deaths are recorded as 0. The registry also lists efficacy and other secondary outcomes, but their numerical results and detailed statistical methods are not reported in the registry record. The safety counts are descriptive and do not establish causal effects or support a randomized comparison.