Actively Recruiting
A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called pCAR-19B, an anti-CD19 CAR-T cell therapy, for children and adolescents aged 3 to 21 with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). This phase II, multi-center, single-arm, open-label study aims to assess the safety and effectiveness of this treatment in patients who have not responded well to standard therapies or have relapsed after remission. Participants will first undergo leukapheresis to collect their own lymphocytes, which are then modified to create the pCAR-19B cells. Before receiving the CAR-T cell infusion, patients will have lymphodepleting chemotherapy using cyclophosphamide and fludarabine for three consecutive days. Following chemotherapy, the pCAR-19B cells will be infused intravenously at a target dose based on body weight. During the study, patients will be closely monitored for responses and side effects up to two years after infusion. Assessments will include measuring the objective response rate at three months, minimal residual disease, survival outcomes, and adverse events related to the treatment. Researchers will also study the pharmacokinetics and pharmacodynamics of the infused cells, along with immunogenicity and other biological markers. The study's total duration and follow-up ensure thorough evaluation of treatment impact and safety.
CONDITIONS
Brief 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 refractory or relapsed criteria
- Malignant cells express CD19 confirmed by flow cytometry
- Bone marrow blast count of 5% or higher at screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Expected survival of at least 12 weeks
- Normal cardiac function with ejection fraction above 50% and no ECG abnormalities
- Renal function with serum creatinine ≤2.0 times upper limit of normal (ULN)
- Liver function with ALT and AST ≤5.0 times ULN
- Total bilirubin ≤2.0 times ULN (or ≤3.0 times ULN for Gilbert syndrome)
- Blood oxygen saturation ≥92% without oxygen support
- No serious mental disorders
- Eligible for apheresis or venous blood collection without contraindications
- Use of reliable contraception for childbearing age participants from consent to one year after infusion
You will not qualify if you...
- Relapse of isolated extramedullary disease
- Active central nervous system leukemia grade 2 or 3 at screening
- Prior CAR-T or other gene-modified cell therapy
- Previous anti-CD19 drug treatment
- Chemotherapy, targeted therapy, or radiotherapy within 14 days before screening
- Positive for active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus infections
- 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 or moderate to severe chronic graft-versus-host disease within four weeks before screening
- Recent cerebrovascular accident or 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 trials within specified washout periods
- Pregnancy, breastfeeding, or planning pregnancy within one year after infusion
- Other conditions deemed unsuitable by investigators
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 to 2 weeks
Participants undergo leukapheresis to collect lymphocytes, receive lymphodepleting chemotherapy for 3 consecutive days, followed by infusion of CD19 CAR T-cells.
Multiple visits including leukapheresis, 3 days of chemotherapy, and CAR T-cell infusion
Duration - Up to 2 years
Participants are monitored for response and safety after CAR T-cell infusion.
Regular visits during the first 3 months and periodic visits up to 2 years
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
Y
Yicheng Zhang, M.D
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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