A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
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)
1 other identifier
interventional
47
1 country
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2023
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
ExpectedAugust 12, 2025
August 1, 2025
2.3 years
December 5, 2022
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Remission Rate (ORR)
ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC)
within 3 months
Secondary Outcomes (16)
Overall complete Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators
within 3 months
Overall Remission Rate (ORR) as determined by IRC and Investigators
at the end of month 3
Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators
at the end of Month 3
Best overall response (BOR)
up to 2 years
Duration of remission (DOR)
to data cutoff date
- +11 more secondary outcomes
Study Arms (1)
Single dose of CNCT19
EXPERIMENTALA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
Interventions
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously. Lymphodepletion treatment: Drugs:Fludarabine Drugs: Cyclophosphamide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active Central Nervous System (CNS) involvement by malignancy.
- Isolated extra-medullary disease relapse.
- Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
- History of concomitant genetic syndrome
- Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
- Active systemic autoimmune disease
- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).
- Patients with active infections at screening.
- Patients who received specified chemotherapy before CNCT19 infusion
- 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.
- Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion.
- Has had treatment with any prior CAR-T therapy.
- Life expectancy \< 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaofan Zhu, M.D
Institute of Hematology & Blood Diseases Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 28, 2022
Study Start
February 7, 2023
Primary Completion
May 30, 2025
Study Completion (Estimated)
May 30, 2027
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Currently the investigators have no plan of interim anaylsis, the investigators don't plan to share individual participant data(IPD) during the trial on-going.