Trial Outcomes & Findings for LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04) (NCT NCT03725605)
NCT ID: NCT03725605
Last Updated: 2025-12-05
Results Overview
The total T-cell level was measured at baseline and end of Step 1. Change from baseline was listed as absolute change. Data cannot be presented on subject-level and are therefore presented as the arithmetic mean value for the factor increase (+) or decrease (-) in number of cells/mm2 from baseline to end of Step 1.
COMPLETED
PHASE2
6 participants
15 to 42 days
2025-12-05
Participant Flow
Participant milestones
| Measure |
LTX-315 plus TIL infusion
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
LTX-315 plus TIL infusion
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Overall Study
Unsuccessful TIL expansion
|
2
|
Baseline Characteristics
LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
Baseline characteristics by cohort
| Measure |
LTX-315 Plus TIL Infusion
n=6 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 15 to 42 daysPopulation: For 1 subject evaluation was not possible due to complete necrosis of the injected lesion
The total T-cell level was measured at baseline and end of Step 1. Change from baseline was listed as absolute change. Data cannot be presented on subject-level and are therefore presented as the arithmetic mean value for the factor increase (+) or decrease (-) in number of cells/mm2 from baseline to end of Step 1.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=5 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
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)
|
1.9 factor change in cells/mm2
Interval -0.6 to 6.9
|
PRIMARY outcome
Timeframe: Up to 133 daysPopulation: AEs related to LTX-315 treatment were evaluated for the 6 subjects completing Step 1. AEs related to LTX-315 treatment in combination with adoptive T-cell therapy were evaluated for the 4 subjects completing Step 2.
AEs were events occurring during or after administration of the IMP. AEs were coded using MedDRA version 21.1 and were classified by System Organ Class (SOC), Preferred Term (PT) and Lowest Level Term (LLT). Adverse events related to LTX-315 were events where causality to LTX-315 was marked on the adverse events page. Adverse events related to the combination of LTX-315 and adoptive T-cell therapy were events where both causality to LTX-315 and at least one of the other IMPs (TILs, Sendoxan®, Fludara® and Proleukin®) were marked on the adverse event page.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=6 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Adverse Events (AE) Related to LTX-315 or to the Combination of LTX-315 and Adoptive T-cell Therapy From Baseline (Step 1, Week 1, Day 1) to End of Treatment (EoT) (Step 2, Week 7)
AEs related to LTX-315 treatment during Step 1.
|
14 events
|
|
Adverse Events (AE) Related to LTX-315 or to the Combination of LTX-315 and Adoptive T-cell Therapy From Baseline (Step 1, Week 1, Day 1) to End of Treatment (EoT) (Step 2, Week 7)
AEs related to LTX-315 treatment in combination with adoptive T-cell therapy during Step 2
|
0 events
|
SECONDARY outcome
Timeframe: Up to 133 daysPopulation: The change in CD3+CD8+ T-cells from baseline to end of Step 2 could only be evaluated for 1 subject.
The change is described as factor change in CD8+ cells/mm2.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=1 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Change in CD3+CD8+ T Cell Density in Non-injected Tumour Tissues From Baseline (Step 1, Week 1, Day 1) to EoT (Step 2, Week 7)
|
3.3 factor change in CD8+ cells/mm2
Interval 3.3 to 3.3
|
SECONDARY outcome
Timeframe: 41 to 49 days between Step 1 and Step 2Population: TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. For 2 subjects it was not possible to meet the criteria of 4x10\^7 cells as described in the IMPD.
The composition of the TIL infusion product was evaluated for the subjects for whom it was possible to grow TILs.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Total Number of CD3+CD8+ T-cells in TIL Infusion Product
|
8032 million CD8+ T-cells
Interval 210.0 to 23177.0
|
SECONDARY outcome
Timeframe: 41 to 49 days between Step 1 and Step 2Population: The composition of the TIL infusion product was evaluated for the 4 subjects for whom it was possible to grow TILs. For 2 subjects it was not possible to meet the criteria of 4x10\^7 cells as described in the IMPD.
The composition of the TIL infusion product was evaluated for the subjects for whom it was possible to grow TILs.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
% CD3+CD8+ T-cells of Total CD3+ in TIL Infusion Product
|
17 %CD8+ of total CD3+ T-cells in TILs
Interval 1.0 to 52.0
|
SECONDARY outcome
Timeframe: EoT (Step 2, Week 7) and up to 15 months after EoT.Population: ORR was evaluated for the 4 subjects who progressed to Step 2.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Objective Response Rate
ORR at EoT (Step 2, Week 7)
|
0 participants
|
|
Objective Response Rate
ORR at up tp 15 months after EoT
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: The endpoint was evaluated for the 4 subjects who progressed to Step 2.
The clinical benefit rate (CBR) was defined as proportion of subjects who according to RECIST 1.1 had achieved complete response, partial response or stable disease at EoT (Step 2, Week 7) and up to 15 months after EoT. CBR was evaluated at Step 2, Week 7 and Week 13.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Clinical Benefit Rate
CBR at up to 15 months after EoT (Week 13)
|
1 participants
|
|
Clinical Benefit Rate
CBR at EoT (Step 2, Week /)
|
3 participants
|
SECONDARY outcome
Timeframe: Assessed at Visit 25 (Step 2, Week 7, Day 42)Population: Evaluated for the 4 subjects who progressed to Step 2.
Best overall tumour response rate (BOR) was defined in the CSP as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Best Overall Tumour Response Rate
Progressive disease
|
1 Participants
|
|
Best Overall Tumour Response Rate
Stable disease
|
3 Participants
|
SECONDARY outcome
Timeframe: Days from screening (Baseline) until date of progressive disease or up to 15 months after EoT.Population: Endpoint evaluated for the 4 subjects who progressed to Step 2.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Progression Free Survival
|
153 days
Interval 72.0 to 208.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 15 monthsPopulation: Endpoint evaluated for the 4 subjects who progressed to Step 2.
Tumour-antigen Specific T-cells in Tumour Tissue and Peripheral Blood Mononuclear Cells antigen specificity assessed by enzyme-linked immuno-spot assay (ELISPOT) and flowcytometry analysis of cytokines including interferon gamma (IFNγ) and tumour necrosis factor alpha (TNF⍺)
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=4 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Number of Participants With Tumour-antigen Specific T-cells in Tumour Tissue and Peripheral Blood Mononuclear Cells
Induced T-cell response against cancer testis antigens
|
3 participants
|
|
Number of Participants With Tumour-antigen Specific T-cells in Tumour Tissue and Peripheral Blood Mononuclear Cells
Induced T-cell response against predicted neo-peptides
|
1 participants
|
|
Number of Participants With Tumour-antigen Specific T-cells in Tumour Tissue and Peripheral Blood Mononuclear Cells
Induced T-cell response against autologous tumour cell line
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 15 monthsPopulation: This endpoint was evaluated for 2 subjects only.
Systemic immune effect of the treatment was assessed by sequencing the TCR repertoire in the peripheral blood mononuclear cells (PBMCs), the TIL product and the biopsies. The outcome of this endpoint is described as the number of subjects for whom a systemic immune effect (in terms of expansion of a significant number of T-cell clones in the blood) was observed.
Outcome measures
| Measure |
LTX-315 plus TIL infusion
n=2 Participants
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Changes in Immunological Parameters From Baseline (Step 1, Week 1, Day 1) to 15 Months After EoT
|
2 participants
|
Adverse Events
LTX-315 plus TIL infusion
Serious adverse events
| Measure |
LTX-315 plus TIL infusion
n=6 participants at risk
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Infections and infestations
Bacteraemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Injury, poisoning and procedural complications
Fascial rupture
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Hypoglycaemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
Other adverse events
| Measure |
LTX-315 plus TIL infusion
n=6 participants at risk
LTX-315 intratumoural injection, TILs expansion and infusion.
LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 4 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Gastric disorder
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 6 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Injection site pain
|
66.7%
4/6 • Number of events 9 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Localised oedema
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
General disorders
Pyrexia
|
66.7%
4/6 • Number of events 6 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Infections and infestations
Oral fungal infection
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Blood alkaline phosphatase decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Blood magnesium decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Blood potassium decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Blood sodium decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • Number of events 8 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • Number of events 4 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Transaminases decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Investigations
Weight increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Nervous system disorders
Facial paresis
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6 • Number of events 3 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Number of events 1 • AEs were collected from the day the subject signed the informed consent and for up to 15 months.
|
Additional Information
Director Scientific Research Baldur Sweinbjornsson
Lytix Biopharma AS
Results disclosure agreements
- Principal investigator is a sponsor employee The PI has the right to publish the study results in scientific or other journals, or to present the study results at professional conferences or other meetings. The PI may use the study results solely for internal research and/or educational purposes and shall not externally publish or present any such results until the earlier of (i) the date of the first study results publication, agreed by the parties and (ii) the end of the 18 month period following the completion of the study.
- Publication restrictions are in place
Restriction type: OTHER