drugset / Trial / NCT05262673

NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL

NCT05262673

Phase 1 Recruiting 10 enrolled Shenzhen Geno-Immune Medical Institute
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) based on multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T lymphocytes (CTLs) and immune-modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negative in B-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.

Timeline

Start
2026-06-01
Primary completion
2029-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CAR-T Cell therapy
Subject STAPULDENCEL Vaccine
Subject cytotoxic T lymphocyte Cell therapy