Actively Recruiting
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
Led by Juventas Cell Therapy Ltd. · Updated on 2025-08-12
47
Participants Needed
9
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 informed consent by patient and/or parent or legal guardian before any study procedures
- Age between 3 and 18 years with weight at least 10 kg
- Diagnosis of relapsed or refractory acute lymphoblastic leukemia (ALL)
- CD19 tumor expression confirmed in bone marrow or peripheral blood within 3 months before screening
- Bone marrow showing 5% or more lymphoblasts at screening
- Karnofsky performance status 70 or higher for age 16 and above, or Lansky performance status 50 or higher for under 16 at screening
- Adequate kidney and liver function
You will not qualify if you...
- Active central nervous system involvement by cancer
- Isolated relapse 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 or moderate to severe chronic graft-versus-host disease within 4 weeks before screening
- Active systemic autoimmune disease
- Known HIV infection or chronic hepatitis B or C infection
- Active infections at screening
- Prior chemotherapy as specified before CNCT19 infusion
- Radiotherapy completed less than 4 weeks ago for non-CNS sites or less than 8 weeks ago for CNS sites
- Donor lymphocyte infusion stopped less than 6 weeks before CNCT19 infusion
- Previous CAR-T therapy
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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