Exploring Safety, Effectiveness, and Behavior of CT1182 Injection in Adults Aged 18-75 With Relapsed or Resistant B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating CT1182, an in vivo CAR-T cell therapy, in patients with relapsed or refractory B-cell Non Hodgkin Lymphoma rr B-NHL. This early phase 1, open-label study aims to explore the safety, effectiveness, metabolic behavior, and pharmacodynamics of CT1182 cells. The study intends to identify the maximum tolerated dose MTD by testing four dose levels, with a target toxicity probability of 30%, to understand how the treatment affects patients with various subtypes of B-NHL. Participants will receive intravenous infusions of CT1182 at escalating dose levels ranging from 1.2 108 to 1.2 109 TU. The dose escalation follows a Bayesian Optimal Interval design, with safety monitored over a 28-day dose-limiting toxicity DLT observation period after the first infusion. If no DLT is observed, doses may be adjusted if ineffective expansion of CAR-T cells is detected, early withdrawal or continued safety observation is possible. The study plans to enroll between 3 and 24 participants, with dosing and cohort size adjusted according to ongoing results. During the study, participants will be closely monitored for adverse events, DLTs, and response rates for up to 24 months after infusion. Evaluations include clinical assessments, laboratory tests, and measurement of CAR gene copy numbers at multiple timepoints. Outcome measures include safety profiles, objective and complete response rates, duration and time to remission, progression-free survival, overall survival, and metabolic kinetics of the lentiviral vectors used in treatment. The study follows participants through long-term safety and efficacy assessments to better understand CT1182s impact.

A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma