Co-administration of CART22-65s and huCART19 for B-ALL

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephan Grupp MD PhD
Study ID
NCT05674175
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B Lineage Lymphoblastic Lymphoma
  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s) — BIOLOGICAL
    CART22-65s are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD22 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain
  • Autologous, humanized anti-CD19 CAR T cell therapy (huCART19) — BIOLOGICAL
    HuCART19 cells are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD19 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain

Study Details

This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

Key Dates

First listed
Jan 6, 2023
Start date
Jan 25, 2023
Status verified
Mar 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

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

Arms

  • Experimental: Dose Finding Arm
    Phase 1 will evaluate the safety of co-administration of CART22-65s with huCART19 in patients who experienced a disease relapse after prior CAR T cell therapy. There is no planned dose escalation but a dose-deescalation will be made based on the incidence of Dose Limiting Toxicities
  • Experimental: Expansion Arm
    If at least one dose level of phase 1 is determined to be safe, the phase 2 dose expansion phase of the trial will be opened to enrollment. Subjects will receive the highest dose of CART 22-65s and huCART19 cells that were determined to be safe. 2 cohorts are planned: Cohort A (relapsed/refractory, CAR T cell naïve) \& Cohort B (prior treatment with a prior CAR T cell product).

Primary Outcome Measure

Safety of CART22-65s and huCART19 co-administration [ Time Frame: 1 year ]

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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