🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06785519
Recruiting Phase EARLY_PHASE1

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

NCT06785519 · tracked via the Priya Life Science China tracker
Sponsor
He Huang
Phase
Phase EARLY_PHASE1
Started
2025-01-31
Last updated
2025-01-21

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang Recruiting

More He Huang trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785519 on ClinicalTrials.gov ↗ ← All trials in China