NCT04169932

The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Longyao Biotechnology Inc., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.

Detailed description

The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg). Each CD20-CART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers. The observation period was 4 weeks after the end of the course of treatment. If 2 or more cases of DLT occurred at a certain dose level, the prior dose level was the maximum tolerable dose of (MTD). If one case of DLT occurred, 3 subjects were added to the group. If there were no DLT in 3 cases, the next dose level would be estimated. If at least 1 case of DLT occurred in the 3 cases, the prior dose was the maximum tolerated dose of (MTD). If there were no DLT at the maximum dose, the maximum tolerant dose was the maximum dose.

Conditions

• Relapsed and Refractory B Cell Lymphoma
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD20 CAR-T	The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg).

Timeline

• Start date: 2019-11-22
• Primary completion: 2022-11-22
• Completion: 2022-11-22
• First posted: 2019-11-20
• Last updated: 2019-11-20

Locations

1 site across 1 country: China