Phase 2
N=6
LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
Soft Tissue Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT03725605 ↗Enrolled (actual)
6
Serious AEs
50.0%
Results posted
Nov 2023
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LTX-315 and TILs (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lytix Biopharma AS
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| PRIMARY 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) |
14; 0 | — |
| SECONDARY 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 | — |
| SECONDARY Total Number of CD3+CD8+ T-cells in TIL Infusion Product |
8032 | — |
| SECONDARY % CD3+CD8+ T-cells of Total CD3+ in TIL Infusion Product |
17 | — |
| SECONDARY Objective Response Rate |
0; 0 | — |
| SECONDARY Clinical Benefit Rate |
3; 1 | — |
| SECONDARY Best Overall Tumour Response Rate |
3; 1 | — |
| SECONDARY Progression Free Survival |
153 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03725605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.