Actively Recruiting
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2024-07-31
100
Participants Needed
10
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
CONDITIONS
Official Title
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian agrees to participate and signs informed consent
- Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) meeting criteria for refractory or relapsed disease
- Malignant cells in bone marrow express CD19 confirmed by flow cytometry
- Bone marrow blasts are 5% or more at screening
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Expected survival of at least 12 weeks
- Normal important organ function including cardiac ejection fraction ≥50%, serum creatinine ≤2.0 times upper limit of normal (ULN), ALT and AST ≤5 times ULN, total bilirubin ≤2.0 times ULN (or ≤3.0 for Gilbert syndrome), and blood oxygen saturation ≥92% without oxygen
- No serious mental disorder
- Meets standards for apheresis or venous blood collection without contraindications
- Use of reliable contraception from consent signing to one year after infusion for subjects of childbearing potential
You will not qualify if you...
- Relapse limited to isolated extramedullary disease
- Active central nervous system leukemia at screening (grade 2 or 3) unless improved after treatment
- Prior CAR-T or gene-modified cell therapy
- Previous anti-CD19 drug treatment
- Recent chemotherapy, targeted therapy, radiotherapy within 14 days or 5 half-lives before screening
- Active infections including hepatitis B or C, HIV, syphilis, or cytomegalovirus above normal ranges
- Severe heart conditions including NYHA class III or IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled infection requiring systemic treatment within one week before screening
- Grade 2-4 acute graft-versus-host disease or moderate to severe chronic GVHD within four weeks
- Recent cerebrovascular accident or epileptic seizure within six months
- Active autoimmune diseases
- Other malignancies within five years except certain treated cancers
- Live attenuated vaccine within four weeks before screening
- Participation in other interventional clinical studies within specified timeframes
- Pregnancy, breastfeeding, or plans for children within one year after infusion
- Any other condition deemed inappropriate by investigators for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Beijing Children's Hospital.Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
Pediatric Hematology department of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
4
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Xiehe Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
6
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
7
Children's Hospital Of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
8
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
9
West China Second University Hospital,Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
10
Institute Of Hematology&Blood Diseases Hospital,Chinese Academy Of Medicai Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
T
Tianyou Wang, M.D
CONTACT
Y
Yicheng Zhang, M.D
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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