Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies

The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.

Trial Details

NCT ID
NCT06408194
Phase
PHASE1
Sponsor
Stanford University
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • CD22CART infusion
  • Tisagenlecleucel
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
  • Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or lat…
  • CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level o…
  • Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.

For full eligibility, visit ClinicalTrials.gov.

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