NCT06474676

T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To find a recommended dose of attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas (has come back or spread to other parts of the body, respectively). To further test the dose found in Part A to see if it can help to control liposarcoma growth.

Detailed description

Primary Objectives Part A. Determine the safety, maximum tolerated dose and/or recommended phase 2 dose of T cell membrane-anchored tumor- targeted IL12 (attIL12)-TIL cell therapy in combination with cyclophosphamide in participants with advanced/metastatic soft tissue or bone sarcomas Part B. Characterize the safety and tolerability and assess preliminary efficacy of attIL12 TIL cells in combination with cyclophosphamide by evaluating the 4-month progression free survival rate (PFS 4 months) in participants with recurrent unresectable liposarcoma Secondary Objectives 1\) Evaluate the anti-tumor efficacy achieved following adoptive transfer of T cell membrane- anchored tumor- targeted IL12 (attIL12)-TIL cell therapy in combination with cyclophosphamide in participants with advanced/metastatic soft tissue or bone sarcomas Exploratory Objectives 1. Characterize the immune response following adoptive transfer of attIL12 TIL cell therapy in paired in pre-treatment and on-treatment tumor specimens and peripheral blood samples 2. Assess collagen and FAP changes in pre-treatment and on-treatment tumor specimens and correlate with clinical benefit/anti-tumor response 3. Determine changes in cell surface vimentin (CSV)-positive circulating tumor cells (CTCs) in peripheral blood before and after adoptive transfer of T cell membrane-anchored tumor- targeted IL12 (attIL12)-TIL cell therapy and correlate with clinical benefit/anti-tumor response

Conditions

• Metastatic Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given by IV
DRUG	T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy	Given by IV

Timeline

• Start date: 2025-09-29
• Primary completion: 2030-12-31
• Completion: 2032-12-31
• First posted: 2024-06-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study