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Recruiting Early Phase 1

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

NCT06785519 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Early Phase 1
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)

  • 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 \[Safety and Tolerability\]

Trial sites (1)

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