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)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:
• Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
• Age 3 to 18. Weight ≥10kg
• Relapsed or refractory acute lymphoblastic leukemia (ALL).
• Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
• Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \< 16 years) performance status ≥ 50 at screening
• Organ function requirements: All patients must have adequate renal and liver functions
Locations
Other Locations
China
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
Guangzhou Women and Children's Medical Center
RECRUITING
Guangzhou
Nanfang Hospital
NOT_YET_RECRUITING
Guangzhou
The Second Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The First Affilicated Hospital of Nanchang University
RECRUITING
Nanchang
Children's Hospital of Nanjing Medical University
RECRUITING
Nanjing
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science of Technology
NOT_YET_RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Contact Information
Primary
Hui Ding
dinghui@juventas.cn
+86-010-65960098
Time Frame
Start Date:2023-02-07
Estimated Completion Date:2027-05-30
Participants
Target number of participants:47
Treatments
Experimental: Single dose of CNCT19
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.