CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

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 leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.

Eligibility Criteria

This trial is for children and young adults aged 1-26 with CD19+ Leukemia that's relapsed multiple times. Participants must have a certain level of physical fitness, adequate organ function, no severe infections or other health conditions that could interfere with the treatment, and not be pregnant. They should also agree to long-term follow-up.

Inclusion Criteria

My lymphocyte count is high enough for the trial.

My leukemia has returned and shows specific markers after initial treatment.

My leukemia has returned at least twice and tests positive for CD19.

+13 more

Exclusion Criteria

I haven't taken any corticosteroids in the last week.

I have a primary immunodeficiency or bone marrow failure.

I do not have any major brain-related health issues.

+11 more

Participant Groups

The study tests genetically modified T cells designed to attack leukemia by recognizing a protein called CD19 on cancer cells. It aims to find the highest safe dose of these CAR+ T cells and assess their toxicity as well as effectiveness in treating leukemia.

1Treatment groups

Experimental Treatment

Group I: CAR+ T cellsExperimental Treatment1 Intervention

Subjects will receive two days of cyclophosphamide for a total of 3g/m\^2 followed several days later by a single dose of Autologous CD19 CAR+ EGFTt + T cells