Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephan Grupp MD PhD
Study ID
NCT05480449
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B Cell Acute Lymphoblastic Leukemia (B-ALL)
  • B Lineage Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
0 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) — BIOLOGICAL
    The investigational agent in this protocol is humanized CART19 cells (huCART19). Autologous T cells will be engineered to express an extracellular single chain antibody (scFv) with specificity for CD19. This will be expected to redirect specificity of the transduced T cells for cells that express CD19, a molecule that is restricted in expression on the surface of the malignant cells and on normal B cells.

Study Details

This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).

Key Dates

Start date
Sep 20, 2022
Status verified
May 2026
Primary completion
Sep 20, 2027
Completion
Sep 20, 2029

Study Design

Enrollment
115 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Arm
    The phase 1 dose escalation portion of the trial will use a standard "3+3" design to establish the recommended phase 2 dose of huCART19 cells in patients with subjects with prior treatment with CD19-directed CAR T cells. Two dose escalations of huCART19 are planned for the dose escalation phase.
  • Experimental: Dose Expansion Arms
    If at least one dose level of the dose escalation phase is determined to be safe, the phase 2b dose expansion phase of the trial will be opened to enrollment. Subjects will receive the highest dose of huCART19 cells that were determined to be safe in the dose escalation part of the trial. 2 cohorts are planned: * Cohort A (relapsed/refractory, CAR T cell naïve) * Cohort B (prior treatment with CD19-directed CAR T cells)

Primary Outcome Measure

Safety of huCART19 Administration [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
CART Nurse Navigator
[email protected]
445-942-5891
Melissa Varghese, M.S.
[email protected]
8455535358

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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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