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A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)

RecruitingPhase 1, Phase 2Ages 3 Years - 18 YearsAllJuventas Cell Therapy Ltd.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria: 1. Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian) 2. Age 3 to 18. Weight ≥10kg 3. Relapsed or refractory acute lymphoblastic leukemia (ALL). 4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening. 5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening. 6. Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \< 16 years) performance status ≥ 50 at screening 7. Organ function requirements: All patients must have adequate renal and liver functions Key Exclusion Criteria: 1. Active Central Nervous System (CNS) involvement by malignancy. 2. Isolated extra-medullary disease relapse. 3. Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis 4. History of concomitant genetic syndrome 5. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening. 6. Active systemic autoimmune disease 7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive). 8. Patients with active infections at screening. 9. Patients who received specified chemotherapy before CNCT19 infusion 10. Radiotherapy before CNCT19 infusion: Non-CNS site of radiation completed \< 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed \< 8 weeks prior to CNCT19 infusion. 11. Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion. 12. Has had treatment with any prior CAR-T therapy. 13. Life expectancy \< 3 months.
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What it tests

  • single dose of CNCT19
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Where

9 sites
The Second Hospital of Anhui Medical University
Hefei, China
Children's Hospital of Chongqing Medical University
Chongqing, China
Guangzhou Women and Children's Medical Center
Guangzhou, China
Nanfang Hospital
Guangzhou, China
Union Hospital Tongji Medical College Huazhong University of Science of Technology
Wuhan, China
Children's Hospital of Nanjing Medical University
Nanjing, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
The First Affilicated Hospital of Nanchang University
Nanchang, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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