CART123 Cells With or Without Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephan Grupp MD PhD
Study ID
NCT07464951
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

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

Interventions

  • Anti-CD123 LV redirected T cells (CART123) — BIOLOGICAL
    CART123 cells: lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains.
  • Ruxolitinib (JAKAVI®) — DRUG
    Ruxolitinib: an orally administered janus-activated kinase (JAK) inhibitor that selectively inhibits JAK1 and JAK2.

Study Details

This study is designed to evaluate the safety and effectiveness of CART123 cells either alone or when combined with ruxolitinib in pediatric and young adult subjects with relapsed or refractory AML. Subjects will be enrolled into one of two treatment cohorts: subjects who will receive CART123 alone (Cohort A) or subjects who will receive CART123 in combination with ruxolitinib (Cohort B).

Key Dates

Start date
May 14, 2026
Status verified
May 2026
Primary completion
May 14, 2029
Completion
May 14, 2030

Study Design

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

Arms

  • Experimental: Cohort A
    In Cohort A, the treatment regimen will consist of lymphodepleting chemotherapy followed by CART123 infusion with planned dose escalation. Subjects enrolled on Cohort A will receive a standard regimen of fludarabine (30 mg/m2/day x 4 days) and cyclophosphamide (500 mg/m2/day x 2 days).
  • Experimental: Cohort B
    In Cohort B, the treatment regimen will consist of lymphodepleting chemotherapy and ruxolitinib followed by a fixed dose of CART123 cells and age and body surface area-adjusted dose of ruxolitinib. Subjects enrolled on Cohort B will receive the regimen fludarabine (30 mg/m2/day x 4 days) and cyclophosphamide (1000 mg/m2/day x 3 days).

Primary Outcome Measure

Evaluate the Safety of CART123 [ 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, MS
[email protected]

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

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