Actively Recruiting
A Clinical Study Evaluating CD19/BCMA CAR-T Cell Therapy for Safety and Effects in Refractory or Relapsed Lupus Nephritis
Led by He Huang · Updated on 2025-01-21
9
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
H
He Huang
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD19/BCMA CAR-T cell therapy in patients with refractory or relapsed lupus nephritis, a serious kidney condition caused by systemic lupus erythematosus. This early phase 1 clinical study builds on previous research that confirmed the safety of this treatment, aiming to expand the number of participants and gather more detailed safety and effectiveness data. Participants will receive an intravenous infusion of CD19/BCMA Lupus Nephritis targeted CAR T-cells. The study involves close observation to assess the treatment's impact on the disease, focusing on patients who have not responded to at least two standard immunosuppressive therapies or who have experienced a relapse. Treatment is delivered as a single infusion, and patients will be monitored over the long term. During the study, participants will undergo regular assessments to track dose-limiting toxicities up to 28 years after treatment and to record treatment-emergent adverse events for up to 2 years. Researchers will evaluate clinical responses and safety through laboratory tests, clinical evaluations, and ongoing follow-up. The study requires informed consent and adherence to contraceptive measures for participants of childbearing potential throughout the study and for six months afterward.
CONDITIONS
Official Title
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of systemic lupus erythematosus (SLE) with biopsy-confirmed grade III, IV, or V lupus nephritis
- SLEDAI-2K score of 8 or higher during screening
- Failure to respond to two or more standard immunosuppressive therapies or experienced a relapse
- Expected survival longer than 12 weeks
- Fertile women and men agree to use contraception before, during, and for 6 months after treatment
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of brain trauma, unconsciousness, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Prolonged QT interval on ECG or severe heart diseases such as serious arrhythmias
- Active untreated infections
- Active hepatitis B or C virus infection
- Use of more than 20mg per day prednisone or equivalent systemic steroids within 1 week before treatment (except inhaled steroids)
- Previous use of any gene therapy products
- Insufficient cell response to CD3/CD28 stimulation
- ALT or AST levels more than 3 times normal or bilirubin above 2.0 mg/dl
- Other uncontrolled diseases deemed unsuitable by the researcher
- HIV infection
- Any condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
Y
Yongxian Hu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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