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

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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