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Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
Sponsor: Kara Yakhteh Tajhiz Azma Company
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
Official title: A Phase I/II Single Arm Study, Safety and Efficacy Assessment of the CD19 CAR T Cell on Pediatric Patients with Relapsing or Refractory B Cell Acute Lymphoblastic Leukemia (r/r B-ALL)
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2024-05-20
Completion Date
2027-09-22
Last Updated
2024-10-10
Healthy Volunteers
No
Interventions
anti-CD19 CAR T cell therapy
Anti-CD19 CAR-T cell therapy for R/R B-ALL pediatric patients. For patients 50 kg and less: 0.2 to 5 in ten to the power of six live CAR+ T cells per kilogram of body weight/ For patients over 50 kg: 0.1 to 2.5 in ten to the power of eight live CAR+ T cells (without considering weight).
Locations (1)
Pediatric cell and gene therapy research center, Children medical center
Tehran, Tehran Province, Iran