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

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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