Study of Combination Immunotherapy Using CAR-T Cells, Cytotoxic T Cells, and Dendritic Cell Vaccine for Treating T-cell Acute Lymphoblastic Leukemia Using NGS-MRD Assessment

What this Trial Is About

Researchers are evaluating a combination immunotherapy approach for treating T-cell acute lymphoblastic leukemia T-ALL, which is an aggressive blood cancer affecting both children and adults. The study aims to determine if using multi-antigen-targeted chimeric antigen receptor T cells CAR-T followed by engineered immune effector cytotoxic T cells CTLs and an immune-modified dendritic cell vaccine DCvac can achieve deep remission as measured by next-generation sequencing minimal residual disease NGS-MRD negativity. This could identify patients with a very low risk of relapse and potential long-term remission without further treatment. The treatment involves giving participants multi-targeted CAR-T cell infusions, then administering antigen-specific CTLs and the DC vaccine designed to boost the immune response against T-ALL cells. These therapies target specific tumor antigens to enhance anti-tumor immunity. The study evaluates the feasibility, safety, and efficacy of this combination immunotherapy approach, focusing on achieving undetectable leukemia cells through sensitive NGS-MRD testing. Participants will be monitored for treatment-related side effects, clinical response, and the percentage of minimal leukemia residue in bone marrow over one year. Researchers will perform laboratory tests to assess organ function and immune responses. This phase 1 trial will follow patients closely with assessments to evaluate safety and effectiveness, aiming for long-lasting remission and reduced relapse risk. The total study duration extends through 2030, with ongoing evaluation of participants health and treatment outcomes.

NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL