Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial

This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell t

Trial Details

NCT ID
NCT06326008
Phase
PHASE1
Sponsor
Beijing GoBroad Hospital
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • \- Patients will be enrolled only if they meet all the inclusion criteria.
  • Patients with relapsed or refractory CD19+/CD22+ (FCM \>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to …
  • Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia, unsuitable/unable to collect autologous lymphocytes;
  • 1 to 18 years old;

For full eligibility, visit ClinicalTrials.gov.

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