Clinical trial · Interventional
LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
An Open Label Phase II Single Centre Study Investigating the Safety and Efficacy of LTX-315 and Adoptive T-cell Therapy in Patients With Advanced/Metastatic Soft Tissue Sarcoma (ATLAS-IT-04)
NCT03725605CI-TRIAL-00098473completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ATLAS-IT-04 is a two part, single arm study designed to determine the safety and effectiveness of LTX-315 to induce T-cell infiltration prior to TIL expansion in patients with soft tissue sarcoma. Following intratumoural injection of LTX-315 to a selected lesion, the lesion will be extracted for T-cell culture, expansion and infusion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LTX-315 and TILs | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LTX-315 plus TIL infusion
- description
- LTX-315 intratumoural injection, TILs expansion and infusion.
- interventionNames
- Combination Product: LTX-315 and TILs
Primary outcomes (2)
- measure
- 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)
- timeFrame
- 15 to 42 days
- description
- 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.
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced/metastatic soft tissue sarcoma that is stable or has progressed on or after minimum 1 line of systemic treatment of advanced/metastatic disease * At least 1 index lesion accessible for injection * At least 1 measurable non-injected lesion that can be used for response willing to undergo repeat biopsy and tumour resection procedures * Age between 18 and 75 years * ECOG performance status of 0-1 * Meet following blood laboratory criteria: ANC \>/= 1.5, Platelet count \>/=75, - Haemoglobin \>/=6mmol/L, AST and ALT \</=2.5 x ULN, Creatinine \</=1.5 ULN * Willing to comply with the protocol requirements and follow-up * Signed informed consent Exclusion Criteria: * A history of clinically significant active systemic autoimmune disease requiring anti inflammatory or immunosuppressive therapy within the last 3 months * Other active malignancy within the previous 5 years except for carcinoma in situ of cervix, ductal r lobular carcinoma in situ of the breast * Received an investigational drug within 4 weeks prior to receipt of study drug * Received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to LTX-315 administration or have not recovered from AEs (to\</= grade 1) Palliative radiotherapy to non target and lesions planned for LTX-315 injection within 4 weeks of LTX-315 administration is allowed * Currently taking any agent with a known effect on the immune system. Stable doses of corticosteroids(up to 10mg prednisolone or equivalent) are permitted for at least 2 weeks prior to LTX-315 administration * Any serious illness or medical condition such, but not limited to: uncontrolled infection or infection requiring antibiotics, uncontrolled cardiac failure, uncontrolled systemic and gastrointestinal inflammatory conditions, bone marrow dysplasia * Known to test positive for HIV/AIDs, syphilis, human T-cell leukemia-lymphoma virus, active Epstein Barr, hepatitis B or C. * history of cerebro- or cardio-vascular disorders and would be of particular risk of sequelae following a hypotensive episode * If of child bearing potential, not willing to use effective form of contraception * Breastfeeding and/or have a positive pregnancy test * Donate sperm from start to 3 months after study treatment * Expected to need any other anticancer treatment or immunotherapy during the treatment period * Clinically active or unstable central nervous system metastases
References
Publications (1)
- DERIVEDNielsen M, Monberg T, Sundvold V, Albieri B, Hovgaard D, Petersen MM, Krarup-Hansen A, Met O, Camilio K, Clancy T, Stratford R, Sveinbjornsson B, Rekdal O, Junker N, Svane IM. LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate tumor specific T cells in patients with metastatic soft tissue sarcoma. Oncoimmunology. 2023 Dec 7;13(1):2290900. doi: 10.1080/2162402X.2023.2290900. eCollection 2024. PMID 38125722