Phase I Clinical Study of CD19-targeting CAR-T Cell (MC-1-50) for Relapsed/Refractory CD19-positive B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are conducting a phase I clinical trial to evaluate the safety, tolerability, and behavior of the MC-1-50 cell formulation, a CD19-targeted CAR-T cell therapy, in adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma. This study also aims to preliminarily observe how well this treatment works in this patient population. The MC-1-50 product is developed on the PrimeCAR platform, which allows for a shorter cell preparation time of about 3 days, potentially improving efficiency and reducing costs. Participants will receive a single intravenous infusion of MC-1-50 cells after lymphodepletion. The study uses a "3+3" dose-escalation design with four dose groups, ranging from 1x10^5/kg to 10x10^5/kg CAR-positive cells, with a maximum of 1x10^8 total CAR-positive cells. All subjects are treated with this investigational CD19 CAR-T cell therapy during the trial. During the study, participants will be closely monitored for treatment-emergent adverse events over one month to assess safety and tolerability. Additional evaluations over three months will include measuring response rates such as objective response, complete and partial responses, as well as the pharmacokinetics and immunogenicity of the MC-1-50 cells. The study involves clinical assessments, laboratory tests, and imaging to evaluate disease status and treatment effects throughout the follow-up period.

Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma