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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

Relapse/Refractory B-cell Acute Lymphoblastic Leukemia

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

Inclusion Criteria8

  • Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
  • Presence of disease in the bone marrow
  • Able to tolerate the apheresis process
  • Life expectancy \> 12 weeks
  • Lansky or Karnofsky score \> 50%
  • At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
  • Informed consent
  • Having potential donor for stem cell transplantation

Exclusion Criteria9

  • Presence of active malignancy other than the disease under study
  • Chloroma and leukemic infiltration on MRI or significant neurological symptoms
  • Any CNS disorder
  • Presence of active GVHD
  • Radiation therapy within last 14 days
  • History of Anti-CD19 or Anti-CD20 therapy
  • Donor lymphocyte injection or other cell therapy methods within the last 30 days
  • Presence of severe active infection
  • Organ dysfunction

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