CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

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.

Trial Details

NCT ID
NCT06777979
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Fludarabine
  • Cyclophosphamide
  • Mesna
  • CD19-CD22 CAR T cell infusion
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • Age \<21 years old
  • Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
  • \*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
  • Second or greater relapse

For full eligibility, visit ClinicalTrials.gov.

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