A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
NCT ID: NCT05667506
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2023-02-07
2027-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single dose of CNCT19
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
single dose of CNCT19
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.
Lymphodepletion treatment:
Drugs:Fludarabine Drugs: Cyclophosphamide
Interventions
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single dose of CNCT19
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.
Lymphodepletion treatment:
Drugs:Fludarabine Drugs: Cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
3 Years
18 Years
ALL
No
Sponsors
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Juventas Cell Therapy Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaofan Zhu, M.D
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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 Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ningling Wang, Dr.
Role: primary
Xianmin Guan, Dr.
Role: primary
Yingyi He, Dr.
Role: primary
Hongsheng Zhou, Dr.
Role: primary
Heng Mei, Dr.
Role: primary
Yongjun Fang, Dr.
Role: primary
Kailin Xu, Dr.
Role: primary
Fei Li, Dr.
Role: primary
Other Identifiers
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HY001103
Identifier Type: -
Identifier Source: org_study_id
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