NCT06389305

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	peripheral blood lymphocytes	autologous or allogeneic peripheral blood lymphocytes
DRUG	CIK cell	autologous or allogeneic cytokine-induced killer (CIK) cells

Timeline

• Start date: 2024-05-27
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2024-04-29
• Last updated: 2026-02-25

Locations

1 site across 1 country: China