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

Conditions

• Metastatic Soft-tissue Sarcoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given by IV
• T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy — DRUG
  Given by IV

Study Details

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.

Key Dates

Start date

Sep 29, 2025

Status verified

Feb 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2032

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part A,
  Participants enrolled in Part A, the dose of attIL2-TIL cell therapy a participant receive will depend on when the participant joins this study. The first group of participants will receive the lowest dose level of attIL2-TIL cell therapy. Each new group will receive a higher dose of attIL2-TIL cell therapy than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of attIL2-TIL cell therapy is found.
• Experimental: Part B
  Participants enrolled in Part B, will receive attIL2-TIL cell therapy at the recommended dose that was found in Part A.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Neeta Somaiah, MBBS
  (713) 792-3626
  [email protected]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
  PHASE1 · Recruiting · Washington University School of Medicine · St Louis, Missouri