A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma
brief summary
This study is a single arm, open label, dose exploring clinical study to evaluate the safety, efficacy, metabolic kinetics and pharmacodynamics of CT1182 cells in patients with relapsed / refractory B-cell non Hodgkin lymphoma (r/r B-NHL).
detailed description
The MTD target toxicity probability of this study is set at 30%. Four dose levels are tentatively determined for dose increment: 1.2 × 10 \^ 8, 3.0 × 10 \^ 8, 6.0 × 10 \^ 8, 1.2 × 10 \^ 8 Tu CT1182. It is planned to enroll 3-24 participants. The number of cases in each dose group shall be subject to the actual situation. The dose increment method of Boin design was used for dose increment. If the exploration dose is not confirmed as the possible maximum tolerated dose (MTD), the investigator and the sponsor can jointly discuss whether to increase to a higher dose or decrease to a lower dose to explore the possible MTD. The observation period of DLT was 28 days after the first infusion. If no obvious expansion of CD19/CD20 car-t cells is detected within 28 days after infusion, the researchers judged that the treatment may be ineffective due to the low infusion dose, or the study participants may withdraw from the treatment early due to disease progression and other reasons, and it is still necessary to continue to observe the safety of the study participants until the 28 day observation period is completed. If DLT is not observed, and the investigator evaluates that the dose of this dose group is too low to benefit the patients, the dose group can no longer continue to be included in the study participants, but can continue to climb the dose of the next dose group. The main purpose of this study was to explore the safety and tolerability of CT1182 among the study participants. The primary endpoint was to evaluate the frequency, type and severity of adverse events after CT1182 infusion, as well as DLT and MTD.