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NCT07896213

Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below.

  1. Start date pushed from Nov 1, 2026 to Feb 1, 2027
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Determine the maximum tolerated dose (MTD) of CD19-CD34t metabolically programmed CAR-T cell therapy in adult patients with CD19-positive B-cell acute lymphocytic leukemia (B-ALL).
Timeframe: 28 days
Assess the safety of CD19-CD34t metabolically programmed CAR-T cell therapy
Timeframe: 28 days
Determine the feasibility of manufacturing CD19-CD34t metabolically programmed CAR-T cell therapy within 15% of the target dose.
Timeframe: 28 days

Secondary (10)

Overall remission rate (ORR)
Rate of MRD-negative CR in bone marrow
Stem cell transplantation prior to leukemia relapse
Rate of B cell aplasia reinduction
ORR after 2nd infusion
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Rate of CR/CRi without stem cell transplantation or other subsequent therapy
Rate of CD19-negative relapse
Progression-free survival (PFS)
Duration of response (DOR)
Overall survival (OS)

Arms and interventions

Cohort 1a - Relapsed/Refractory B-ALLExperimental

Adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) receiving lymphodepleting chemotherapy followed by CD19-CD34t metabolically programmed CAR-T cell therapy.

Cohort 1b - B-ALL in remission with measurable residual diseaseExperimental

Adult patients with CD19-positive B-cell acute lymphoblastic leukemia in remission with measurable residual disease (MRD) receiving lymphodepleting chemotherapy followed by CD19-CD34t metabolically programmed CAR-T cell therapy.

Cohort 1c - B-ALL in Remission, Indicated but Unable to Undergo Allogeneic TransplantExperimental

Adult patients with CD19-positive B-cell acute lymphoblastic leukemia in MRD-negative remission who are indicated for but unwilling to undergo or ineligible for allogeneic stem cell transplantation due to organ dysfunction, socioeconomic factors, or other reasons determined by the transplant physician. These patients receive lymphodepleting chemotherapy followed by CD19-CD34t metabolically programmed CAR-T cell therapy.

Retreatment Cohort - Patients from cohorts 1a - 1c who are retreatedExperimental

Patients previously treated in Cohort 1a, Cohort 1b, or Cohort 1c who meet protocol-defined eligibility criteria for retreatment and receive lymphodepleting chemotherapy followed by a second infusion of CD19-CD34t metabolically programmed CAR-T cells.

Drugs: Fludarabine, Cyclophosphamide, Levetiracetam, CD19 CAR-T cells

Sites

1 site in 1 country

  • Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina, United States