A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age ≥18 years old;

• 2\. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.

• 3\. SLEDAI-2K ≥8 during screening

• 4\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);

• 5\. Expected survival \>12 weeks;

• 6\. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);

• 7\. Volunteer to participate in this experiment and sign the informed consent.

Locations
Other Locations
China
The first affiliated hospital of medical college of zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, MD
hehuangyu@126.com
0571-87233772
Backup
Yongxian Hu, MD
huyongxian2000@aliyun.com
0571-87233772
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 9
Treatments
Experimental: Lupus Nephritis
Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: He Huang

This content was sourced from clinicaltrials.gov