Spots Global Cancer Trial Database for A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
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Trial Identification
Brief Title: A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Official Title: A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL
Study ID: NCT05334823
Interventions
Study Description
Brief 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.
Detailed Description: This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 0.6-2 x106 cells/kg.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Children's Hospital.Capital Medical University, Beijing, Beijing, China
Beijing GoBroad Boren Hospital, Beijing, Beijing, China
Pediatric Hematology department of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiehe Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
The Second Xiangya Hospital, Central South University, Changsha, Hunan, China
Children's Hospital Of Soochow University, Suzhou, Jiangsu, China
The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China
West China Second University Hospital,Sichuan University, Chengdu, Sichuan, China
Institute Of Hematology&Blood Diseases Hospital,Chinese Academy Of Medicai Sciences, Tianjin, Tianjin, China
Contact Details
Name: Tianyou Wang, M.D. Ph.D
Affiliation: Beijing Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Liang Huang, M.D. Ph.D
Affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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