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Brief Title: A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
Official Title: A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
Study ID: NCT05667506
Brief Summary: This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
Detailed Description: This trial is a multi-center, open label, single-arm, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 in Children and Adolescent(aged 3\~18 years old) patients (pediatric) with r/r B-cell ALL. The phase Ib part of the trial is to evaluate the safety, optimal dose of CNCT19, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Children and Adolescent patients with r/r B-cell ALL. The phase II part of the trial is to evaluate the efficacy and safety of CNCT19 in in the treatment of Children and Adolescent patients with r/r B-cell ALL. The study includes screening, pre-treatment (Cell Product manufacture \& lymphodepletion), CNCT19 infusion , safety and efficacy follow-up, and survival follow-up. All subjects who have received CNCT19 infusion will be followed for up to 2 years.
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing, China
Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science of Technology, Wuhan, Hubei, China
Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Affilicated Hospital of Nanchang University, Nanchang, Jiangxi, China
Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China
Name: Xiaofan Zhu, M.D
Affiliation: Institute of Hematology & Blood Diseases Hospital, China
Role: PRINCIPAL_INVESTIGATOR