Actively Recruiting
Safety and Feasibility Study of CD19 Chimeric Antigen Receptor T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma
Led by Hong Kong Children's Hospital · Updated on 2025-03-10
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of using a special type of modified immune cell called CD19-CAR T cells in children aged 1 to 17 years who have relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. These immune cells are designed to target a protein called CD19 found on cancer cells. The study aims to confirm the safety of this treatment and observe how well it works in these children after they have received chemotherapy to prepare their bodies. Participants will receive a single intravenous infusion of CAR-T cells at a dose based on their body weight, following a chemotherapy regimen to reduce immune cells and help the CAR-T cells work better. This treatment is given once during the study, and the children are closely monitored afterward. The study is sponsored by Hong Kong Children's Hospital and does not include a placebo or comparison group. During the study, children will have regular assessments including blood tests to measure response to treatment, scans to track disease status, and checks for side effects. The main outcomes measured are the complete response rate for ALL within one month and overall response rate for lymphoma within three months. Safety is monitored throughout an average follow-up period of six months, with additional assessments of survival and treatment success up to one year. Participation involves visits for evaluation, treatment, and follow-up over this time frame.
CONDITIONS
Brief Title
CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 17 years
- Diagnosed with relapsed or refractory acute lymphoblastic leukemia or lymphoma after at least two lines of therapy
- Disease must be CD19 positive by recent biopsy or flow cytometry
- Performance status: Karnofsky score ≥ 50% if over 10 years old; Lansky score ≥ 50% if 10 years or younger
- Normal organ function with specified limits for bilirubin, liver enzymes, and creatinine
- Adequate blood counts: Hemoglobin > 8 g/dL, lymphocytes > 0.1x10^9/L, platelets > 50x10^9/L
- At least 2 weeks since prior systemic therapy or 5 half-lives, whichever is shorter
- Parent or guardian able and willing to give informed consent
You will not qualify if you...
- Autologous transplant within 6 weeks of planned CAR-T infusion
- Prior CAR-T cell therapy outside this study
- Active central nervous system or meningeal tumor involvement
- History of other active cancers except certain skin cancers or carcinoma in situ
- Active HIV infection
- Uncontrolled illness such as infection, heart failure, unstable angina, arrhythmia, lung problems, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- Evidence of myelodysplasia on bone marrow biopsy
- Active hepatitis B or C infection based on serology
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 - Single infusion with follow-up to 1 month for initial response assessment
Participants receive a single intravenous infusion of CAR-T cells (CHXCART01) at a dose based on body weight.
1 infusion visit and multiple follow-up visits up to 1 month
Duration - Up to 6 months for adverse event monitoring and up to 1 year for survival outcomes
Participants are monitored for safety and overall outcomes including adverse events and survival.
Regular visits over 6 months and extended survival follow-up up to 1 year
Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Daniel Cheuk, MBBS
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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