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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Dose-limiting toxicity (DLT) [Time frame: Up to 28 years after Treatment]
• Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]

Secondary outcome measures (1)

• Urinary protein index [Time frame: Up to 24 hours after Treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The first affiliated hospital of medical college of zhejiang university — Hangzhou

Identifiers

NCT: NCT06785519 · TXB2024012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗