Modified TIL Cell Therapy for Sarcoma

Recruiting in Palo Alto (17 mi)

Neeta Somaiah | MD Anderson Cancer Center

Overseen byNeeta Somaiah, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people aged 12 and older with advanced or metastatic soft tissue or bone sarcoma, who have had at least one prior systemic therapy unless no standard treatment exists. Participants must be willing to use birth control and have adequate organ function. Pregnant women, those with certain health conditions like uncontrolled illnesses, a history of primary immunodeficiency, active infections, or autoimmune diseases are excluded.

Inclusion Criteria

I am 12 years old or older.

It's been over 2 weeks since I had radiation therapy on any cancer area not being tested.

I am a man willing to use birth control during and for 3 months after the study if my partner can become pregnant.

+9 more

Exclusion Criteria

My side effects from previous cancer treatments are mild or managed, except for hair loss or hearing loss.

I have had a primary immunodeficiency, organ transplant, or tuberculosis.

I have not received a live vaccine in the last 28 days.

+10 more

Participant Groups

The study is testing the safety and effectiveness of attIL12-TIL cell therapy in patients with relapsed or metastatic sarcomas. It aims to determine an optimal dose that can manage liposarcoma growth. The trial includes pre-treatment with cyclophosphamide before administering the TIL cell therapy.

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment2 Interventions

Participants enrolled in Part B, will receive attIL2-TIL cell therapy at the recommended dose that was found in Part A.

Group II: Part A,Experimental Treatment2 Interventions

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.