CAR T Cell Therapy for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

Overseen byCatherine Albert, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Seattle Children's Hospital

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for children and young adults with hard-to-treat solid tumors. It uses the patient's own immune cells, modified to better attack cancer cells. The study aims to see if this approach is safe and effective. This type of therapy has shown remarkable results in young patients with certain types of blood cancers.

Research Team

Catherine Albert, MD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

This trial is for children and young adults up to 26 years old with certain relapsed or refractory solid tumors. They must have a life expectancy of at least 8 weeks, be recovered from previous treatments, have adequate organ function and lab values, and not be pregnant or breastfeeding. Participants over 15 must agree to use effective contraception.

Inclusion Criteria

My condition has not improved or has returned after treatment.

I haven't received any antibody cancer treatment for the last 30 days or 3 half-lives, whichever is shorter.

I stopped all chemotherapy at least 7 days before joining.

See 14 more

Exclusion Criteria

I have a current brain or spinal cord condition.

Unwilling or unable to provide consent/assent for participation in the study and 15 year follow up period

I am currently suffering from a severe infection.

See 6 more

Treatment Details

Interventions

B7H3 CAR T Cell Immunotherapy (CAR T-cell Therapy)

Trial OverviewThe study tests genetically modified T cells targeting B7H3 in non-CNS solid tumors. It has two arms: one receives only B7H3-specific CAR T cells; the other also targets CD19+ B cells. The goals are to assess safety, dose tolerance, cell persistence in the body, and anti-tumor effects.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: SCRI-CARB7H3(s)x19 plus pembrolizumabExperimental Treatment2 Interventions

Autologous CD4+ and CD8+ T-cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab

Group II: SCRI-CARB7H3(s)x19Experimental Treatment1 Intervention

Autologous CD4+ and CD8+ T-cells genetically modified to a bispecific B7H3xCD19 CAR

Group III: SCRI-CARB7H3(s)Experimental Treatment1 Intervention

Autologous CD4+ and CD8+ T-cells genetically modified to express an B7H3-specific CAR