Adoptive Cell Therapy for Sarcoma

Recruiting in Palo Alto (17 mi)

Overseen byJohn Mullinax, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single-arm trial that will evaluate the safety and feasibility of the Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo following treatment

Research Team

John Mullinax, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for adolescents and young adults with high-grade soft tissue sarcoma who have tried at least one standard treatment. They must be in fairly good health, not pregnant or nursing, and free from serious infections or immune system diseases. Participants should not need chronic steroids, have autoimmune diseases requiring immunosuppression, or active brain metastases.

Inclusion Criteria

My kidney, liver, and blood tests are within normal ranges.

A negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential.

I meet all the requirements for the study at the time of my tumor removal and TIL expansion.

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Exclusion Criteria

I am not on long-term steroids for immune suppression.

I've completed a specific chemotherapy aimed at boosting my immune system.

I do not have any active infections, bleeding disorders, or major illnesses affecting my heart, lungs, or immune system.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Fludarabine (Anti-metabolites)
Interleukin-2 (Cytokine)
Tumor-infiltrating lymphocyte (TIL) (CAR T-cell Therapy)

Trial OverviewThe trial tests Tumor-infiltrating lymphocyte (TIL) therapy combined with drugs Cyclophosphamide, Interleukin-2, and Fludarabine to see if they're safe and how well the TILs survive after treatment. It's a single-arm study where all participants receive the same experimental therapy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Infusion of Tumor-infiltrating lymphocyteExperimental Treatment4 Interventions

Participants will undergo tumor resection from which the tumor infiltrating lymphocyte (TIL) product will be generated. All participants will receive nonmyeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T-cell persistence and effectiveness in vivo. Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS). Fludarabine will then be infused at 25 mg/m\^2 intravenous piggyback (IVPB). All participants will receive not less than 10\^9, and up to 1x10\^12 T cells in ≥250 mL NS as an inpatient by intravenously (IV). Eight (8) to sixteen (16) hours after completing the T cell infusion, all participants will receive high-dose interleukin-2 (IL-2) on an inpatient basis at the standard dose of 600 000 IU/kg as an intravenous bolus over an approximate 15-minute period every 8 to 16 hours for up to 15 doses on days 1 to 5, as tolerated.