LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)

NCT03725605 | Completed Phase 2 Results

• 1 other identifier: C17-315-04 (ATLAS-IT-04)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  15 to 42 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)

  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.

  Up to 133 days

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)

  Up to 133 days

• Total Number of CD3+CD8+ T-cells in TIL Infusion Product

  41 to 49 days between Step 1 and Step 2

• % CD3+CD8+ T-cells of Total CD3+ in TIL Infusion Product

  41 to 49 days between Step 1 and Step 2

• Objective Response Rate

  EoT (Step 2, Week 7) and up to 15 months after EoT.

• Clinical Benefit Rate

  Up to 15 months

Other Outcomes (2)

• Number of Participants With Tumour-antigen Specific T-cells in Tumour Tissue and Peripheral Blood Mononuclear Cells

  Up to 15 months

• Changes in Immunological Parameters From Baseline (Step 1, Week 1, Day 1) to 15 Months After EoT

  Up to 15 months

Study Arms (1)

LTX-315 plus TIL infusion

EXPERIMENTAL

LTX-315 intratumoural injection, TILs expansion and infusion.

Combination Product: LTX-315 and TILs

Interventions

LTX-315 and TILs COMBINATION_PRODUCT

Intratumoural injection of LTX-315 and infusion of TILs

LTX-315 plus TIL infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lytix Biopharma AS: lead
• Herlev Hospital: collaborator

Study Sites (1)

Herlev Hospital

Copenhagen, DK-2730, Denmark

Location

Related Publications (1)

• Nielsen 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 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

LTX-315

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Director Scientific Research Baldur Sweinbjornsson
• Organization: Lytix Biopharma AS

Baldur.Sveinbjornsson@lytixbiopharma.com

+47 413 44 682

Study Officials

• Inge Marie Svane, MD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: LTX-315 and TILs

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 31, 2018
• Study Start: December 28, 2018
• Primary Completion: July 2, 2021
• Study Completion: October 11, 2021
• Last Updated: December 5, 2025
• Results First Posted: November 8, 2023

Record last verified: 2023-11

Locations

DK (1)