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

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).

Trial Details

NCT ID
NCT07464951
Phase
PHASE1
Sponsor
Stephan Grupp MD PhD
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Anti-CD123 LV redirected T cells (CART123)
  • Ruxolitinib (JAKAVI®)
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • 1\. Age at time of consent: Cohort A: 0-29 years. Cohort B: 1-29 years (Note: the first subject at each dose level of Cohort B must be ≥12 years old)
  • 2\. Subjects with AML in second or greater relapse, post-transplant relapse, or with chemotherapy-refractory disease. Specifically:
  • Second or greater relapse defined as bone marrow flow cytometric confirmation of myeloid leukemia of at least 0.1% or development of extramedullary…
  • Any detectable disease post-allogeneic transplant with bone marrow flow cytometric confirmation of myeloid leukemia of at least 0.1% or development…

For full eligibility, visit ClinicalTrials.gov.

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