Safety, Efficacy and Pharmacokinetics of XKDCT023 in DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

Official title: Safety, Efficacy and Pharmacokinetics of XKDCT023 in Adult Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma

Status Not yet recruiting

Clinical Trial Summary

This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. The first dose group has one patient. If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be enrolled according to the "3 + 3" method; The follow-up dose group is conducted according to the traditional "3 + 3" design, that is, three subjects are first enrolled in a dose group. If there is no dose limiting toxicity (DLT) in the three patients in the dose group, it can be increased to the next higher dose after completing the DLT observation period; If DLT occurs in 1 of the 3 patients in the dose group, it is necessary to continue to enroll 3 patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to 1 of the last 6 confirmed patients will be defined as MTD. The safety of car-t treatment was evaluated by observing the adverse events after cell therapy; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion, the number and activity of car-t cells were detected, and the pharmacokinetics (PK) of car-t cells was evaluated.

Clinical Trial Description

This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There were three dose groups in the study, and one patient in the first dose group, If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be included in the group according to the "3 + 3" method; the follow-up dose group is designed according to the traditional "3 + 3" design, that is, three subjects will be included in a dose group first, if there is no dose limiting toxicity in the three patients in the dose group (DLT), after completing the DLT observation period, it can be increased to the next higher dose; if one of the three patients in the dose group has DLT, it is necessary to continue to join the group of three patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to one of the six patients finally confirmed will be defined as MTD. By observing the adverse events after cell therapy, the patients will be evaluated Evaluate the safety of car-t treatment; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion to detect the number and activity of car-t cells, Evaluate the pharmacokinetics (PK) of car-t cells. During the study, the blood samples used for the production of car-t cells will be transported to Shenzhen xiankangda Life Sciences Co., Ltd. (sponsor). After the production of car-t cells is completed, the car-t cells will be sent to the research unit so that the researchers can infuse them to the corresponding subjects. ;

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT05269914
• Study type: Interventional
• Source: The Affiliated Hospital of Qingdao University
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Completion date: June 30, 2023