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NCT05334823
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Conditions: Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
Sex: All
Ages: 3 Years – 21 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: Chongqing Precision Biotech Co., Ltd
Location: Beijing Children's Hospital.Capital Medical University Beijing Beijing Municipality
Summary
This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Eligibility Criteria
Inclusion Criteria:
1. The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research;
2. Diagnosed with B-ALL,and meet one of the following conditions:
1. Refractory B-ALL: early-stage refractory patients who failed to achieve complete remission after 2 courses of standard induction chemotherapy;
2. Relapsed B-ALL: patients with early relapse (\
Source: ClinicalTrials.gov (NCT05334823). StuddyBuddy aggregates publicly available trial information.