RecruitingPhase 1Phase 2NCT06635330

Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

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)


Sponsor

Kara Yakhteh Tajhiz Azma Company

Enrollment

5 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-T cell therapy for children and teenagers with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) — a blood cancer that has come back or stopped responding to treatment. CAR-T therapy involves modifying the patient's own immune cells to recognize and destroy leukemia cells carrying the CD19 protein on their surface. **You may be eligible if...** - You are between 2 and 18 years old with CD19-positive B-ALL that has relapsed or not responded to treatment - Cancer cells are present in the bone marrow - You are healthy enough to tolerate the cell collection process (apheresis) - Your expected life expectancy is more than 12 weeks - Your physical function score is above 50% - At least 7 days have passed since your last chemotherapy or steroid treatment - A potential stem cell donor is available if needed afterward **You may NOT be eligible if...** - You have another active cancer - You have brain or central nervous system involvement by leukemia, or significant neurological symptoms - You have active graft-versus-host disease (from a prior transplant) - You received radiation within the past 14 days - You have previously received anti-CD19 or anti-CD20 therapies - You had a cell therapy or donor lymphocyte infusion within the past 30 days - You have a severe active infection or significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-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

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NCT06635330