BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL

In this single-center, single-arm, prospective, Phase 1/2 study, the safety and efficacy of autologous BCOR and ZC3H12 genes knock-out CD19-targeting chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with refractory/relapsed (r/r) B-cell acute lymphoblastic leukaemia (B-ALL). In phase 1, 3 eligible patients will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell therapy at a initial dose of 5×10\^5 cells/kg. Based on the results, . Subsequently an additional 3-15 patients will be enrolled in a "3+3" dose-escalation/decline design to adjust the d

Trial Details

NCT ID
NCT07008885
Phase
PHASE1 / PHASE2
Sponsor
Chinese PLA General Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • CAR19TIF cells
  • Fludarabine
  • Cyclophosphamide
Locations (sample)
  • Beijing, Biotherapeutic Department of Chinese PLA General Hospital, China|39.9075,116.39723
  • Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China|39.9075,116.39723

Key Eligibility Criteria

  • Age 18-70 (inclusive),gender unrestricted.
  • Patient with r/r CD19+ B-ALL, as per guidelines (NCCN, 2019)
  • morphologically confirmed with ≥ 5% leukaemic blasts in the bonemarrow;
  • or presenting a quantifiable MRD load of 1x10\^-3 , assessed by multiparameter flow cytometry and/or quantitative polymerase chain reaction, at the…

For full eligibility, visit ClinicalTrials.gov.

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