Actively Recruiting
A Phase Ib/II Multi-center Study Evaluating Safety and Efficacy of CNCT19 in Children and Adolescents with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Led by Juventas Cell Therapy Ltd. · Updated on 2025-08-12
47
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CNCT19 treatment in children and adolescents aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL). This multi-center, open-label, single-arm phase Ib/II trial aims to find the optimal dose and study how the treatment works in this pediatric population. The study includes both initial safety and dosing evaluation and a later phase focused on efficacy and safety. Participants will receive a conditioning chemotherapy regimen with fludarabine and cyclophosphamide before a single intravenous infusion of CNCT19, which consists of autologous 2nd generation CD19-directed CAR-T cells. The study periods include screening, pre-treatment for cell product manufacture and lymphodepletion, infusion of CNCT19, followed by safety and efficacy follow-up, and long-term survival monitoring lasting up to two years after infusion. During the trial, participants will undergo various assessments including monitoring of remission rates within three months, evaluation of minimal residual disease, response duration, survival rates, adverse events, pharmacokinetics, cytokine levels, and immunogenicity. Researchers will also track allogeneic stem cell transplant rates and laboratory abnormalities. Follow-up visits and sample collections will continue for up to two years to comprehensively assess treatment effects and participant safety.
CONDITIONS
Brief Title
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures (patient and/or parent or legal guardian)
- Aged 3 to 18 years old and weighing at least 10 kilograms
- Diagnosed with relapsed or refractory acute lymphoblastic leukemia (ALL)
- Confirmed CD19 tumor expression in bone marrow or peripheral blood within 3 months before screening
- Bone marrow showing at least 5% lymphoblasts by morphologic assessment at screening
- Karnofsky performance status of 70 or higher for ages 16 and older, or Lansky performance status of 50 or higher for under 16 years
- Adequate kidney and liver function
You will not qualify if you...
- Active central nervous system (CNS) involvement by cancer
- Isolated relapse of disease outside the bone marrow
- Diagnosis of Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia, or chronic myelogenous leukemia in blast crisis
- History of genetic syndromes
- Acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening
- Active systemic autoimmune disease
- Known HIV infection or chronic hepatitis B or C infection
- Active infections at screening
- Prior specified chemotherapy before CNCT19 infusion
- Recent radiotherapy: less than 4 weeks for non-CNS sites or less than 8 weeks for CNS-directed radiation before CNCT19 infusion
- Donor lymphocyte infusion (DLI) received less than 6 weeks before CNCT19 infusion
- Previous treatment with any CAR-T therapy
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo cell product manufacture and lymphodepletion chemotherapy with fludarabine and cyclophosphamide before receiving CNCT19 infusion.
Several visits for chemotherapy administration and cell product preparation
Duration - Single day
Participants receive a single intravenous infusion of CNCT19, a 2nd generation CD19-directed CAR-T cell therapy.
1 infusion visit (in-person)
Duration - Up to 3 months
Participants are monitored for safety, treatment response, and pharmacokinetics/pharmacodynamics after CNCT19 infusion.
Weekly visits for up to 12 weeks
Duration - Up to 2 years
Participants who have received CNCT19 infusion are followed for long-term outcomes including relapse-free survival and overall survival.
Periodic visits during follow-up
Trial Site Locations
Total: 9 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
2
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Actively Recruiting
4
Nanfang Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Union Hospital Tongji Medical College Huazhong University of Science of Technology
Wuhan, Hubei, China
Not Yet Recruiting
6
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
7
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
8
The First Affilicated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
9
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
H
Hui Ding
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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