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

Early Phase 1

Recruiting

• Conditions: Lupus Nephritis
• Interventions: Biological: CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

• Registration Number: NCT06785519
• Lead Sponsor: He Huang

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Study Start: 2025-01-31
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lupus Nephritis	CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection	Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 28 years after Treatment	Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)	Up to 2 years after Treatment	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Urinary protein index	Up to 24 hours after Treatment	Urinary protein index（24h urinary protein、Urinary protein/creatinine ratio）

Trial Locations

Locations (1)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China