CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06559189
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
3 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19x22 CAR T — BIOLOGICAL
    The investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.

Study Details

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Key Dates

First listed
Aug 19, 2024
Start date
Sep 27, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Disease Burden Cohort
    ≥25% bone marrow lymphoblasts and/or non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN)design. Dose begins at DL -1(1x10\^5 cells/kg).
  • Experimental: Low Disease Burden Cohort
    \<25% bone marrow lymphoblasts and no non-CNS extramedullary disease. Dose escalation will proceed independently within each cohort using the Bayesian Optimal Interval (BOIN)design. Dose begins at DL1 (3x10\^5 cells/kg).

Primary Outcome Measure

Safety Measured by Dose Limiting Toxicities (DLTs) [ Time Frame: Infusion date to 28 days post-infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Vanessa Fabrizio, MD
[email protected]
720-777-6860
Vanessa Fabrizio, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Colorado· Aurora, CO

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