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 LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04) (NCT03725605), a na phase 2 study. The primary outcome is Change in Total T-cell Level in Tumour Tissues From Baseline (Step 1, Week 1, Day 1) to End of Step 1 (Step 1, Week 3-5).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03725605 |
| Phase | Phase 2 |
| Condition | Soft Tissue Sarcoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Lytix Biopharma AS |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced or metastatic soft tissue sarcoma were eligible for this single-centre study. The registry records an enrollment of 6. The primary-endpoint description notes that evaluation was not possible for 1 subject because the injected lesion had complete necrosis.
Intervention
The treatment sequence combined intratumoural injection of LTX-315 with tumour-infiltrating lymphocyte (TIL) expansion and infusion. A selected lesion was injected, then extracted for T-cell culture and expansion before infusion.
Comparator
There was no control group. The study is listed as single-group, with allocation recorded as not applicable. Its observations therefore describe the treated group; they do not provide a like-for-like comparison with another treatment or with no treatment.
Primary question
The primary endpoint asked how total T-cell levels in tumour tissue changed from baseline to the end of Step 1, over a timeframe of 15 to 42 days. The registry describes the change as a factor increase or decrease in cells/mm2, summarized as an arithmetic mean. A numerical result is not reported in the registry record.
The study’s broader question concerned safety and whether LTX-315 could induce T-cell infiltration before TIL expansion in people with soft tissue sarcoma. The listed secondary outcomes include T-cell density in non-injected tumour tissue, T-cell counts and proportions in the infusion product, tumour response measures, and progression-free survival. These are outcome topics, not evidence by themselves that a particular change or response occurred.
3. Trial Design
ATLAS-IT-04 (NCT03725605) is recorded as a phase II, open-label, single-centre study with a single-group design. The registry lists Lytix Biopharma AS as sponsor and the status as completed. The recorded study start was 2018-12-28, and the primary completion date was 2021-07-02. Enrollment was 6.
The intervention was a sequence rather than a comparison between assigned groups: intratumoural LTX-315 injection, extraction of the selected lesion, TIL culture and expansion, and infusion of the expanded TILs. The intervention is named “LTX-315 and TILs”; the arm description specifies LTX-315 intratumoural injection followed by TIL expansion and infusion.
Open-label means that masking was not used, as also recorded in the registry. The study has no randomized allocation and no control arm. Consequently, it can describe observations among participants receiving the intervention, but the design does not isolate the contribution of LTX-315 from the later TIL procedure or other influences on outcomes. Changes over time within a single group are not equivalent to differences between randomized treatments.
The registry lists 11 outcome measures and no analyses. The primary outcome concerns change in total T-cell level in tumour tissue from baseline at Step 1, Week 1, Day 1, to the end of Step 1, at Step 1, Week 3–5. Its stated timeframe is 15 to 42 days. The outcome description says subject-level data could not be presented and that the change was presented as an arithmetic mean factor increase or decrease. However, the numerical endpoint result and the analysis details are not reported in the registry record.
The listed secondary outcomes cover immune-cell measurements, response measures, and progression-free survival. Their presence indicates what the study planned to assess, but does not establish that results for each outcome are available or that any particular analysis was performed.
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.
Overall Study
| Stage | LTX-315 plus TIL infusion |
|---|---|
| STARTED | 6 |
| COMPLETED | 4 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | LTX-315 plus TIL infusion |
|---|---|
| Unsuccessful TIL expansion | 2 |
Analysis population for the primary outcome, as defined in the registry: For 1 subject evaluation was not possible due to complete necrosis of the injected lesion
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.
| Characteristic | Unit | LTX-315 Plus TIL Infusion |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Denmark | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Total T-cell Level in Tumour Tissues From Baseline (Step 1, Week 1, Day 1) to End of Step 1 (Step 1, Week 3-5), measured over 15 to 42 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | factor change in cells/mm2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint measures change in total T-cell level within tumour tissue between baseline and the end of Step 1. The registry specifies the measurement as a factor change in cells/mm2 and describes the reported value as the arithmetic mean factor increase or decrease from baseline. The intended interval is 15 to 42 days, corresponding to the baseline assessment at Step 1, Week 1, Day 1, and the end-of-Step-1 assessment at Step 1, Week 3–5.
Measuring T-cell levels is relevant to the study’s stated question about inducing T-cell infiltration before TIL expansion. In general, a tissue-level measure can describe whether immune-cell density or abundance changed at the sampled site over the specified interval. It does not, on its own, establish why a change occurred or whether it translates into a clinical outcome.
The registry says subject-level data could not be presented and specifies an arithmetic mean of factor increases or decreases. It also notes that evaluation was not possible for 1 subject because of complete necrosis of the injected lesion. The numerical mean, its full range, and any inferential analysis are not reported in the registry record. Without those results, the direction, magnitude, and precision of the primary-endpoint change cannot be assessed.
More generally, an endpoint definition tells readers what was measured and when; it is not a result. The change measure should not be interpreted as a comparison with an untreated group, because the study has a single-group design.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, single-group investigation of LTX-315 followed by TIL expansion and infusion. Its primary question is biologically focused: whether total T-cell levels in tumour tissue changed between baseline and the end of Step 1. The endpoint is defined in terms of a factor increase or decrease in cells/mm2, summarized as an arithmetic mean. The record does not report the numerical mean or the full range, so it does not show the observed direction or size of change.
The missing primary result is central to interpretation. An endpoint name and measurement schedule cannot establish whether T-cell levels rose, fell, or varied across participants. Nor can readers assess how widely individual changes differed from the mean. The record states that subject-level data could not be presented and that evaluation was not possible for 1 subject due to complete necrosis of the injected lesion. It does not explain the consequences of that issue for the reported summary beyond this statement.
The study has no randomized comparator. Any observed change in the treated group would be descriptive of the sequence of LTX-315 and TIL therapy over time. Without a comparison group, changes cannot be separated from other time-related factors, differences in sampled tissue, or the effects of the combined treatment sequence. The design does not estimate a comparative treatment effect.
The listed secondary outcomes span immune measurements and clinical outcomes, including objective response rate, clinical benefit rate, best overall tumour response rate, and progression-free survival. These measures address different questions and should not be treated as interchangeable. The registry record lists these outcome topics but does not report their numerical results in the registry record for this account. It also lists 11 outcome measures and no analyses, so no statistical conclusion about those secondary outcomes can be drawn.
Safety information is more explicit: serious adverse events affected 3 of 6 participants at risk, and other adverse events affected 6 of 6 at risk. The registry lists five serious adverse-event terms, each with a reported value of 16.7%, and records no deaths. These figures describe events in the study group; they do not establish that the intervention caused the events. Attribution, event timing, severity grading, and exposure-adjusted rates are not reported in the registry record.
Overall, the record supports a description of the study’s design, endpoint definition, enrollment, and listed safety findings. It does not support a conclusion about the magnitude or precision of the primary biological outcome, comparative efficacy, or the causal relationship between treatment and adverse events. Those limits follow from the absent endpoint results and the single-group, open-label design, not from a finding that the intervention did or did not have an effect.
9. Statistical Methods Explained
What does the design allow?
This is a single-group study, not a randomized comparison. In general, a single-group design can document what was observed in participants who received a treatment sequence and can be useful for describing feasibility, safety, and biological measurements. It cannot, by itself, show how those observations compare with what would have happened under a different treatment or without the intervention. Because LTX-315 injection was followed by TIL expansion and infusion, outcomes after the sequence also cannot be attributed separately to one component on the basis of this design alone.
The study is open-label and has no masking. In general, lack of masking can affect subjective assessments, clinical decisions, and reporting, although the extent depends on the outcome and how it is measured. The primary measure is a tissue-cell measurement, but the registry does not report assessment procedures or safeguards against measurement bias. Those details are not reported in the registry record.
How should the primary summary be understood?
The primary endpoint is described as an arithmetic mean of factor increases or decreases in total T-cell level from baseline to the end of Step 1. An arithmetic mean is a summary of the observed values on the scale being averaged. It can be affected by unusually large or small observations, especially when observations are heterogeneous. A factor-change measure is not the same as an absolute change in cell density, even though the endpoint description also refers to cells/mm2. The record says the change was listed as absolute change, then describes the reported summary as the arithmetic mean factor increase or decrease; it does not provide enough numerical detail to reconcile or interpret these descriptions further.
The registry specifies full range as the dispersion measure. In general, a range reports the lowest and highest observed values and gives readers a sense of spread, but it does not describe how values are distributed between those endpoints. Neither the mean nor the full range is numerically reported in the registry record. No confidence interval, standard error, or hypothesis-test result is reported there for the primary outcome.
What does a confidence interval communicate?
In general, a confidence interval is an interval estimate intended to show uncertainty around an estimated quantity under a specified statistical procedure. A narrow interval indicates greater precision under that procedure than a wider one; it does not remove bias or turn an uncontrolled study into a randomized comparison. No confidence interval for the primary endpoint is reported in the registry record, so its statistical precision cannot be evaluated from this record.
Why does sample size matter?
In general, a small study often has limited ability to estimate effects precisely, and individual observations can have substantial influence on summaries. That consideration is relevant to a study with enrollment of 6, but it does not justify calculating a new estimate or inferring what the results would have been. The registry’s primary-endpoint description also notes that evaluation was not possible for 1 subject because of complete necrosis of the injected lesion. It does not report a precision estimate or a statistical test for the endpoint.
The planning assumptions describe an illustrative calculation using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect stated as a fraction of the observed effect. Such planning calculations are hypothetical design illustrations, not observed power. They do not change the trial’s actual single-group design, and any sample-size illustration based on an observed effect depends on the effect used as its starting point. The calculation details and numeric illustrations are not reported in the registry record.
What is the role of the secondary outcomes?
The secondary outcomes include changes in CD3+CD8+ T-cell density in non-injected tumour tissue, T-cell counts and proportions in the TIL infusion product, tumour response measures, and progression-free survival. In general, these outcomes assess different aspects of biology and clinical course. They may involve different measurement scales and analysis choices. The registry lists 11 outcome measures but no analyses; numerical results and analysis methods for the secondary outcomes are not reported in the registry record.
Multiplicity refers generally to the interpretive challenge that can arise when many outcomes or statistical tests are considered. Testing multiple hypotheses can increase the chance of finding at least one apparently unusual result by chance if no suitable strategy is used. The registry does not report a multiplicity procedure or the number of statistical tests conducted. Therefore, it is not possible to determine whether any adjustment was planned or used.
Statistical methods need to match the outcome scale and data structure. In general, count-like or cell-density outcomes may be unevenly distributed, and over-dispersion means that the observed variability exceeds what a chosen model assumes. Appropriate modeling can affect estimated uncertainty. The registry does not report a model for the primary endpoint, an assessment of distributional assumptions, or an over-dispersion analysis. These are general considerations, not claims about analyses performed in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, including the primary tissue T-cell endpoint and several secondary immune and clinical outcomes. It records no analyses. The numerical results and statistical procedures for these outcomes are not reported in the registry record.
Multiplicity is a general concern when several outcomes or statistical tests are evaluated. Without a reported analysis plan, readers cannot tell which outcomes were designated for formal testing, whether outcomes were prioritized, or whether any adjustment for multiple comparisons was used. The registry record does not report a multiplicity strategy. This absence does not establish that no strategy existed; it means that one cannot be assessed from the record.
Information about missing data and analysis populations is also limited. The primary endpoint description states that evaluation was not possible for 1 subject because of complete necrosis of the injected lesion. It does not report the handling of that observation in an analysis, a missing-data method, or whether any sensitivity analysis was performed. Subject-level data could not be presented, according to the endpoint description.
The registry does not report a full definition of the primary analysis population, the number with evaluable measurements at each timepoint, or how missing secondary-outcome data were handled. It also does not report whether any interim analyses occurred. These omissions limit assessment of the analysis choices and of how robust any numerical findings might be. No inference about unreported analyses or missing-data procedures should be made.
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 |
|---|---|---|---|
| LTX-315 plus TIL infusion | 3 | 6 | 50.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LTX-315 plus TIL infusion | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LTX-315 plus TIL infusion | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | LTX-315 plus TIL infusion |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 1 of 6 |
| Abdominal pain | Gastrointestinal disorders | 1 of 6 |
| Bacteraemia | Infections and infestations | 1 of 6 |
| Fascial rupture | Injury, poisoning and procedural complications | 1 of 6 |
| Hypoglycaemia | Investigations | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | LTX-315 plus TIL infusion |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 4 of 6 |
| Nausea | Gastrointestinal disorders | 4 of 6 |
| Injection site pain | General disorders | 4 of 6 |
| Pyrexia | General disorders | 4 of 6 |
| Diarrhoea | Gastrointestinal disorders | 3 of 6 |
| Vomiting | Gastrointestinal disorders | 3 of 6 |
| Fatigue | General disorders | 3 of 6 |
| Neutrophil count decreased | Investigations | 3 of 6 |
| Platelet count decreased | Investigations | 3 of 6 |
| Rash | Skin and subcutaneous tissue disorders | 3 of 6 |
Serious events with the highest arm-level rate: diarrhoea (16.7%), abdominal pain (16.7%), bacteraemia (16.7%), fascial rupture (16.7%), hypoglycaemia (16.7%).
The registry records 3 of 6 participants at risk as affected by serious adverse events and 6 of 6 at risk as affected by other adverse events. It records 0 deaths. These are participant-level summaries of whether events were reported in the listed categories; they are not counts of every individual event.
The serious adverse-event terms listed are diarrhoea, abdominal pain, bacteraemia, fascial rupture, and hypoglycaemia. Each term is accompanied by a reported value of 16.7%. These values should be read as the record’s reported figures, not as a basis for combining terms or estimating an overall event burden. A participant may potentially have more than one event, and the record does not clarify the overlap between terms.
Adverse-event reporting does not, by itself, establish causation. The registry information does not report whether the events were judged related to LTX-315, TIL infusion, the disease, or another cause. Event timing, duration, severity grading, and exposure-adjusted rates are not reported in the registry record. The figures describe safety observations in this study group and should be interpreted within that limited context.
12. What the Result Does, and Does Not, Mean
The record establishes that ATLAS-IT-04 was a completed, open-label phase II study with a single-group design and enrollment of 6. It describes an intervention sequence involving intratumoural LTX-315 followed by TIL expansion and infusion. It also specifies a primary biological endpoint: change in total T-cell level in tumour tissue from baseline to the end of Step 1, expressed as a factor increase or decrease and summarized as an arithmetic mean.
However, the numerical primary-endpoint result is not reported in the registry record. The mean and full range are absent, as are a confidence interval and a statistical test. The record therefore does not show whether the average measure increased or decreased, how large any change was, or how precisely it was estimated. The fact that the endpoint was defined and measured does not itself demonstrate a result.
The design also does not provide a randomized control group. Even if a before-and-after change were reported, it would describe the treated group over time rather than establish the effect of the intervention compared with an alternative. Since LTX-315 and TIL therapy were administered as a treatment sequence, this design would not separate their individual contributions.
The safety figures document serious and other adverse events among participants at risk, and the registry records no deaths. They do not establish that treatment caused or did not cause the events. The record does not report event attribution or other details needed to interpret the circumstances and clinical significance of each event.
Accordingly, the available registry information supports a careful account of the trial’s structure, endpoint definition, and listed safety observations. It does not support a conclusion about efficacy, the size of a biological effect, or comparative benefit. The absence of numerical outcome results should be understood as a limitation of what is reported in the registry record, not as evidence that an outcome was zero or that no measurement occurred.
13. Why This Trial Matters Statistically
This trial is statistically notable for the way it connects a biological endpoint to a complex treatment sequence. The primary measure focuses on total T-cell levels in tumour tissue after intratumoural LTX-315 and before the end of the step that precedes TIL infusion. That endpoint reflects the study’s stated interest in T-cell infiltration, while the listed secondary outcomes extend to immune-cell measures in non-injected tissue and the infusion product, as well as clinical response and progression-free survival.
These outcomes address related but distinct questions. A tissue T-cell measurement is a biological observation; response and progression measures concern clinical course. Keeping those endpoint types separate is important when interpreting a study, because a change in a laboratory or tissue measure does not itself establish a change in clinical outcome.
The single-group design is also important statistically. It can describe observations among participants receiving the sequence, but it cannot provide the protection against confounding that comes from a randomized control group. The open-label structure further means masking was not used. Those design features shape what any findings could establish, irrespective of the magnitude of an observed value.
Finally, the registry record lists the primary endpoint definition and adverse-event summaries but does not report the numerical primary result or analyses. This makes the distinction between an outcome plan and an outcome finding particularly consequential. A precise endpoint definition is useful for understanding what the study intended to measure; without its numerical result and uncertainty, readers cannot judge the observed change. The study therefore illustrates why design, endpoint specification, analysis reporting, and result reporting must be considered together.
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 most direct limitation for interpreting efficacy or biological activity is that the registry record does not report numerical results for the primary endpoint. It also does not report numerical results for the listed secondary outcomes. Although the endpoint description identifies the measurement, timeframe, summary method, and full-range dispersion, readers cannot evaluate the observed magnitude, direction, variability, or statistical precision.
The study’s single-group design provides no randomized comparator. Any change across the measurement period cannot be interpreted as a comparative treatment effect, and the contribution of LTX-315 cannot be separated from the later TIL procedure. The open-label design means masking was not used, while the registry does not describe assessment procedures that could inform the risk of measurement or assessment bias.
The enrollment was 6. The primary-endpoint description states that evaluation was not possible for 1 subject because the injected lesion had complete necrosis. The record does not provide subject-level data, details of the analysis population, or a missing-data approach. It also does not report numerical uncertainty estimates or a statistical test for the primary endpoint.
Several further details are not reported in the registry record: the statistical analysis plan, any multiplicity procedure, the handling of missing secondary outcomes, and whether interim analyses occurred. For safety, event attribution, timing, duration, and severity grading are not reported. These gaps limit interpretation of both outcome findings and the context of adverse events. They should not be replaced with assumptions about procedures that the record does not describe.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04) — NCT03725605.
- Registry record last updated 2025-12-05; status last verified 2023-11.
- Results first posted 2023-11-08.
- 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
ATLAS-IT-04 (NCT03725605) is listed as a completed, open-label, phase II, single-centre, single-group study sponsored by Lytix Biopharma AS. The recorded start date is 2018-12-28, the primary completion date is 2021-07-02, and enrollment is 6.
The intervention combined intratumoural LTX-315 injection with TIL expansion and infusion. The primary endpoint measured change in total T-cell level in tumour tissue from baseline to the end of Step 1, over 15 to 42 days. The registry describes an arithmetic mean factor increase or decrease and full-range dispersion, but does not report the numerical endpoint result. Evaluation was not possible for 1 subject because of complete necrosis of the injected lesion.
The registry lists 11 outcome measures and no analyses. Serious adverse events affected 3 of 6 participants at risk; other adverse events affected 6 of 6 at risk. The record lists five serious-event terms, each reported as 16.7%, and records 0 deaths. It does not report comparative efficacy results or event attribution.