CAR T-Cell Therapy for Leukemia
(PLAT-04 Trial)

Recruiting in Palo Alto (17 mi)

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

Trial Summary

What is the purpose of this trial?Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.

Eligibility Criteria

This trial is for children and young adults (12 months to <27 years old) with CD22+ leukemia or lymphoma that's come back or hasn't responded to treatment. They should have recovered from previous treatments, not be pregnant/breastfeeding, free of severe infections, other cancers, primary immunodeficiencies, and able to tolerate apheresis. Participants must agree to long-term follow-up and use effective contraception if applicable.

Inclusion Criteria

Life expectancy of >8 weeks

I am between 18 and 26 years old.

I am between 12 months and 27 years old.

+19 more

Exclusion Criteria

I do not have any health conditions that would stop me from following the treatment plan.

I cannot undergo apheresis or have a temporary line placed for it.

I am currently suffering from a severe infection.

+5 more

Participant Groups

The study tests a new therapy using the patient's own T-cells genetically modified to target CD22 on leukemia/lymphoma cells. It aims to see if these CAR T-cells are safe and can be produced in sufficient amounts for treatment in those who've relapsed after standard therapies or have resistant disease.

1Treatment groups

Experimental Treatment

Group I: Autologous CD22-specific CAR T-cells expressing EGFRtExperimental Treatment1 Intervention