Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    18
  • sponsor
    Beijing Boren Hospital
Updated on 20 November 2021

Summary

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.

Then this study will be using BOIN1/2 approach from starting dose 1: 110^6 (30%) to dose 2: 210^6 (30%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 510^5 (30%) /kg.

Details
Condition T-cell acute lymphoblastic leukemia
Treatment CD5 CART
Clinical Study IdentifierNCT05032599
SponsorBeijing Boren Hospital
Last Modified on20 November 2021

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