Primary outcomeMean· 15 to 42 days
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)
| Group | Value (factor change in cells/mm2) |
|---|---|
| LTX-315 plus TIL infusion | 1.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataLTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
NCTNCT03725605 (opens ClinicalTrials.gov in a new tab)Other idC17-315-04 (ATLAS-IT-04)
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 6 participants (actual)
- Sponsor
- Lytix Biopharma AS · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Denmark
- Start
- 28 Dec 2018
- Primary completion
- 2 Jul 2021
- Completion
- 11 Oct 2021
- First posted
- 31 Oct 2018
- Last update posted
- 5 Dec 2025
- Conditions
- Soft Tissue Sarcoma
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20182019202020212022
- Ph 2
LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
NCT0372560528 Dec 2018 to 11 Oct 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.
Interventions
- LTX-315 and TILsCombination product
Arms1
Experimental
LTX-315 plus TIL infusion
LTX-315 intratumoural injection, TILs expansion and infusion.
Primary outcomes2
Outcomes the sponsor listed as 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)
Time frame · 15 to 42 days
Registry 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.
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)
Time frame · Up to 133 days
Registry description
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.
Secondary outcomes(7)
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)
Time frame · Up to 133 days
Registry description
The change is described as factor change in CD8+ cells/mm2.
Total Number of CD3+CD8+ T-cells in TIL Infusion Product
Time frame · 41 to 49 days between Step 1 and Step 2
Registry description
The composition of the TIL infusion product was evaluated for the subjects for whom it was possible to grow TILs.
% CD3+CD8+ T-cells of Total CD3+ in TIL Infusion Product
Time frame · 41 to 49 days between Step 1 and Step 2
Registry description
The composition of the TIL infusion product was evaluated for the subjects for whom it was possible to grow TILs.
Objective Response Rate
Time frame · EoT (Step 2, Week 7) and up to 15 months after EoT.
Registry description
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.
Clinical Benefit Rate
Time frame · Up to 15 months
Registry description
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.
Best Overall Tumour Response Rate
Time frame · Assessed at Visit 25 (Step 2, Week 7, Day 42)
Registry description
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).
Progression Free Survival
Time frame · Days from screening (Baseline) until date of progressive disease or up to 15 months after EoT.
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Up to 133 days
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)
| Group | Value (events) |
|---|---|
| LTX-315 plus TIL infusion | 14 |
Secondary and other outcome results(6)
Secondary outcomeMean· Up to 133 days
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)
| Group | Value (factor change in CD8+ cells/mm2) |
|---|---|
| LTX-315 plus TIL infusion | 3.3 |
Secondary outcomeMean· 41 to 49 days between Step 1 and Step 2
Total Number of CD3+CD8+ T-cells in TIL Infusion Product
| Group | Value (million CD8+ T-cells) |
|---|---|
| LTX-315 plus TIL infusion | 8032 |
Secondary outcomeMean· 41 to 49 days between Step 1 and Step 2
% CD3+CD8+ T-cells of Total CD3+ in TIL Infusion Product
| Group | Value (%CD8+ of total CD3+ T-cells in TILs) |
|---|---|
| LTX-315 plus TIL infusion | 17 |
Secondary outcomeNumber· EoT (Step 2, Week 7) and up to 15 months after EoT.
Objective Response Rate
| Group | Value (participants) |
|---|---|
| LTX-315 plus TIL infusion | 0 |
Secondary outcomeNumber· Up to 15 months
Clinical Benefit Rate
| Group | Value (participants) |
|---|---|
| LTX-315 plus TIL infusion | 3 |
Secondary outcomeCount of participants· Assessed at Visit 25 (Step 2, Week 7, Day 42)
Best Overall Tumour Response Rate
| Group | Value (Participants) |
|---|---|
| LTX-315 plus TIL infusion | 3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LTX-315 plus TIL infusionLTX-315 intratumoural injection, TILs expansion and infusion. LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs | 0 / 6 | 3 / 6 | 6 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Clinical trial · 2024
5 results
LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate tumor specific T cells in patients with metastatic soft tissue sarcoma.
Nielsen et al. 2024Oncoimmunologycited by 36
PMID 38125722PMC10732595DOI 10.1080/2162402x.2023.2290900PUB-38125722
Free to read · publisher termsCC BY-NC5 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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