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

Recruiting Phase 1 Interventional Study
B-cell Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, in Relapse
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
1 – 18
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Beijing GoBroad Hospital · Other
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About This 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 ty…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: \- Patients will be enrolled only if they meet all the inclusion criteria. 1. Patients with relapsed or refractory CD19+/CD22+ (FCM \>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to all standard therapies, including, but not limited to…
Contacts

Tengyu Wang

86+18333186020

tengyu.wang@gohealtharo.com

CONTACT