Study of CT1190B CAR-T Cell Therapy for Adults with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety, efficacy, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This clinical study is a single-arm, open-label, dose exploratory trial designed to enroll between 6 and 24 participants. It aims to assess how these CAR-T cells behave and affect the disease in this patient population under medical supervision. Participants will receive infusions of CT1190B and CT1190B-P cells as the experimental treatment. The study does not include a comparison group and focuses on evaluating the dose range and maximum tolerated dose within 28 days after infusion. The treatment involves a single-arm administration of chimeric antigen receptor T cells, and participants will be followed for up to 12 months to monitor responses and safety outcomes. Throughout the study, participants will undergo various assessments including monitoring of the dose effects, overall and complete response rates at multiple time points 4, 8, 12 weeks and 6, 9, 12 months, duration of remission, progression-free survival, and overall survival up to 12 months after treatment. Participants must adhere to a long-term follow-up plan extending up to 15 years as required by regulatory guidelines. Safety evaluations and cellular pharmacokinetics will also be monitored during the study period.

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )