Actively Recruiting
CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
Led by Hong Kong Children's Hospital · Updated on 2025-03-10
18
Participants Needed
1
Research Sites
713 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
CONDITIONS
Official 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
- Relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma treated with at least two prior therapies
- Disease positive for CD19 antigen confirmed by immunohistochemistry or flow cytometry
- Performance status: Karnofsky 60; 50% for children over 10 years, Lansky scale 60; 50% for children 10 years or younger
- Normal organ function with total bilirubin 60; 3 times upper limit of normal, AST and ALT 60; 5 times upper limit of normal, serum creatinine 60; 2 times upper limit of normal
- Adequate blood counts: hemoglobin above 8 g/dL, absolute lymphocyte count above 0.1 x10^9/L, platelet count above 50 x10^9/L
- At least 2 weeks or 5 half-lives have passed since prior systemic therapy before leukapheresis
- Parent or guardian able and willing to provide informed consent
You will not qualify if you...
- Autologous transplant within 6 weeks before planned CAR T cell infusion
- Previous CAR-T cell therapy outside this study
- Active central nervous system or meningeal tumor involvement
- History of other active cancers except non-melanoma skin cancer or carcinoma in situ
- Active HIV infection
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, lung problems, or psychiatric/social issues affecting compliance
- Pregnant or breastfeeding
- Evidence of myelodysplasia or related bone marrow abnormalities before therapy
- Active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Daniel Cheuk, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here