Study of CIK Cell Therapy for Children and Young Adults With Relapsed or Refractory Acute B-Lymphoblastic Leukemia Experiencing Early CAR-T Cell Dysfunction

What this Trial Is About

Researchers are evaluating cytokine-induced killer CIK cell therapy in children and young adults aged 1 to 39 years with relapsed or refractory acute B-lymphoblastic leukemia rr B-ALL who experience early exhaustion of CAR-T cells. This randomized, double-blind trial aims to determine how CIK cell therapy impacts the prognosis of patients facing early functional decline of CAR-T cells, focusing on event-free survival as the primary outcome. Participants will be randomly assigned to one of three groups a control group receiving peripheral blood lymphocytes, a group receiving CIK cell therapy, and a group receiving messenger RNA-modified CIK cell therapy. The study plans to enroll 213 subjects and will compare outcomes such as event-free survival, progression-free survival, duration of response, and overall survival over periods extending up to 15 years. During the study, patients will be closely monitored for their response to the therapies and for any treatment-related events. Measurements include the 2-year event-free survival rate as the primary endpoint, along with secondary outcomes like progression-free survival and overall survival. The trial involves regular assessments to track disease status and therapy effects, with a total participation duration that may extend up to 15 years for long-term follow-up.

CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction