CAR T-Cell Therapy for Neuroblastoma
(GRAIN Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAndras A. Heczey, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial involves treating patients with relapsed or refractory neuroblastoma using specially modified immune cells that can better recognize and attack their cancer. These modified cells are supported by chemotherapy and an additional drug to help them work more effectively. The goal is to see if this approach can safely extend the time these cells stay active in the body and improve their ability to fight cancer.

Eligibility Criteria

This trial is for children with high-risk neuroblastoma that's come back or didn't respond to treatment. They should have normal liver and kidney function, be stable after previous treatments, not have certain allergies, and must not be on immunosuppressive drugs. A key requirement is having T-cells modified to fight cancer ready for infusion.

Inclusion Criteria

Pulse Ox greater than or equal to 90% on room air

Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)

Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies

+14 more

Exclusion Criteria

You have had an allergic reaction in the past to products containing murine protein.

Patients who are pregnant, lactating, or unwilling to use birth control

My cancer is growing quickly.

+6 more

Participant Groups

The study tests a new gene therapy using T cells engineered to target neuroblastoma more effectively by living longer in the body. It includes lymphodepletion chemotherapy (cyclophosphamide and fludarabine) followed by these special T cells plus pembrolizumab to counteract substances released by tumors that weaken immune responses.

3Treatment groups

Experimental Treatment

Group I: iC9-GD2 T cells,Cytoxan,Fludara,KeytrudaExperimental Treatment4 Interventions

Fresh T cells will be given IV over 5-10 mins. There is a possibility for additional doses of iC9-GD2 T cells.

Group II: iC9-GD2 T Cells - frozen - CLOSEDExperimental Treatment1 Intervention

The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells.

Group III: iC9-GD2 T Cells - fresh - CLOSEDExperimental Treatment1 Intervention

The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells.