Actively Recruiting
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
Led by Seoul National University Hospital · Updated on 2023-02-06
5
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19\[cluster of differentiation antigen 19\] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.
CONDITIONS
Official Title
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory CD19 positive acute lymphoblastic leukemia in patients younger than 26 years at consent
- Bone marrow relapse of second or greater, or any relapse after allogeneic stem cell transplant with at least 6 months from transplant to infusion
- Refractory disease defined by no complete remission after 2 cycles of standard chemotherapy or chemorefractory after 1 cycle for relapsed leukemia
- Ineligible for allogeneic stem cell transplant due to severe comorbid disease, contraindications to conditioning, or lack of suitable donor
- Documented CD19 tumor expression in bone marrow or peripheral blood by flow cytometry
- Karnofsky (age 16 and above) or Lansky (under 16 years) performance status of 50 or higher at screening
You will not qualify if you...
- Uncontrolled hepatitis B or hepatitis C infection
- Known human immunodeficiency virus (HIV) infection
- Clinically active uncontrolled infection
- Pregnant or nursing (lactating) women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
H
Hyoungjin Kang, PhD
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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