CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

NCT ID: NCT06785519

Last Updated: 2025-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-10-31

Brief Summary

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

Detailed Description

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lupus Nephritis

Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells

Group Type: EXPERIMENTAL

CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

Intervention Type: BIOLOGICAL

Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion

Interventions

CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• 3. Active infected persons who are not cured:
• 4. Active hepatitis B or C virus infection;
• 5. Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
• 6. Have used any gene therapy products before;
• 7. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals;
• 8. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;
• 9. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
• 10. HIV-infected people;
• 11. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

He Huang

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

0571-87233772

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

0571-87233772

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

0571-87233772

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

0571-87233772

Other Identifiers

TXB2024012

Identifier Type: -

Identifier Source: org_study_id