RecruitingNot ApplicableNCT06389305

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

Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study

Sponsor

Beijing GoBroad Hospital

Enrollment

213 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, in Relapse B-cell Acute Lymphoblastic Leukemia Refractory Acute Lymphoid Leukemia

Summary

This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.

Eligibility

Min Age: 1 YearMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving CIK cell therapy (a type of immune cell treatment grown outside the body) can help children and young adults with relapsed or treatment-resistant B-cell leukemia (B-ALL) whose previous CAR-T cell therapy has stopped working. **You may be eligible if...** - You are between 1 and 39 years old - You have confirmed relapsed or treatment-resistant B-cell ALL - Your previous CAR-T cell therapy has lost its effectiveness within 6 months (but you have not relapsed) - Your general health score (ECOG) is 0–2 and your expected survival is at least 60 days **You may NOT be eligible if...** - You have leukemia that has spread to your brain or spinal fluid - You have a severe allergy history - You have significant organ failure - You are pregnant or breastfeeding 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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