CAR T Cell Therapy for Childhood Acute Lymphoblastic Leukemia

Overseen By Rebecca Epperly, MD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Primary immunodeficiency, HIV, Severe infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Research Team

Rebecca Epperly, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for pediatric patients (≤ 21 years old) with recurrent or refractory leukemia that tests positive for CD19 and/or CD22. It's not suitable for those who don't meet the specific health criteria set by the researchers.

Inclusion Criteria

I am under 21 years old.

Estimated life expectancy of > 12 weeks

I can do most activities but may need help.

Exclusion Criteria

Known primary immunodeficiency

I am HIV positive.

History of hypersensitivity reaction to murine-containing products

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Collection and Manufacturing

Patients will have white blood cells collected through apheresis or use a previously collected frozen product. The cells will be engineered to become CD19-CD22 CAR T cells.

3-4 weeks

Treatment

Eligible patients will receive lymphodepleting chemotherapy followed by CD19-CD22 CAR T cell infusion.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events.

4 weeks

Treatment Details

Interventions

• CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy

Trial Overview The study is testing a new therapy where T cells are modified to target two proteins on leukemia cells, CD19 and CD22. It also involves pre-treatment with chemotherapy drugs Fludarabine and Cyclophosphamide, protected by Mesna.

Participant Groups

Group I: CD19-CD22-CAR T cell therapy Experimental Treatment 4 Interventions

This study has two parts: Collection and Manufacturing Phase - Patients will have white blood cells collected in the St. Jude Blood Donor Center through a procedure called apheresis, or your doctors may use a previously collected frozen product. The collected cells will be engineered to improve their ability to recognize and kill cancer cells. The final cell product is referred to as the CD19-CD22 CAR T cells. Treatment Phase - Eligible patients will receive chemotherapy before receiving the CAR T cells.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+