Medical University of South Carolina
The goal of this trial is to determine safe dosing of CD19-CD34t metabolically programmed CAR-T cell therapy in adult patients with CD19-positive B-cell acute lymphocytic leukemia (B-ALL). The main questions it aims to answer are to determine the maximum tolerated dose (MTD) of CD19-CD34t metabolically programmed CAR-T cell therapy, to assess the safety of CD19-CD34t metabolically programmed CAR-T cell therapy, and to determine the feasibility of manufacturing CD19-CD34t metabolically programmed CAR-T cell therapy within 15% of the target dose.
This is an open-label, single-center phase Ib de-escalation safety and feasibility study in adult patients with CD19-positive B-cell acute lymphocytic leukemia (B-ALL). The trial will evaluate the safety of autologous peripheral blood mononuclear cell (PBMC) obtained by leukapheresis and then transduced with CD19-CD34t CAR retroviral vector followed by conditioning for a metabolically programmed (TH1/TH17) enhanced CAR-T cell product. The design will follow a 3+3+3 de-escalation design. The starting dose (dose level 1 \[DL1\]) is 2 x 106 transduced T cells/kg (±15%), based on the RP2D from NCT…
An individual must meet all of the following criteria to be eligible for enrollment: 1. Age 18 years or older. 2. Willing and able to give written, informed consent to the current study. 3. ECOG performance status of 0, 1 or 2. 4. Relapsed or refractory CD19-positive B-ALL defined as one of the following: 1. Primary refractory disease (not achieving CR after two cycles of induction chemotherapy). 2. Relapse after prior complete remission. 3. Relapsed or refractory disease after allogeneic transplant provided CAR-T infusion occurs at least 2 months after the stem cell transplant.…
30 mg/m2, IV over 30-60 minutes +/- 10 minutes after cyclo- phosphamide infusion, Days -5, -4, -3
500 mg/m2, IV over 30-60 minutes +/- 10 minutes before Fludarabine, Days -4, -3
(500-750 mg BID) is administered prophylactically starting on Day 0.
Autologous CD19 CAR-T cells expressing truncated CD34 (CD34t) administered intravenously following lymphodepleting chemotherapy. Participants receive either Dose Level 1 or Dose Level -1 according to the protocol-defined dose de-escalation design.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.