Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
NCT06635330
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
Inclusion Criteria: * 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 Criteria: * 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
Conditions2
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NCT06635330