Actively Recruiting
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Led by RenJi Hospital · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
832 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
A
AbelZeta Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
CONDITIONS
Official Title
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at the time of signing the informed consent form
- Diagnosed with SLE, IMNM, NMOSD, MS, MG, or SSc for at least 6 months according to recognized criteria
- Active or relapsed disease after at least 8 weeks of stable standard therapy with at least two immunosuppressants, biologics, or disease-modifying drugs
- Adequate bone marrow, coagulation, heart, lung, liver, and kidney function
You will not qualify if you...
- Positive for Hepatitis B, Hepatitis C, HIV, Treponema Pallidum, CMV DNA, or EBV DNA
- Uncontrolled active infection
- Received live vaccine within 4 weeks before signing the informed consent form
- History of major organ or bone marrow/hematopoietic stem cell transplantation
- Severe cardiovascular disease within 6 months before screening
- Grade 2 or higher bleeding within 30 days before screening or requiring long-term anticoagulant treatment
- Inadequate washout period from previous treatments
- Previous treatment with CAR-T cells or genetically modified T cell therapies
- Pregnant or lactating women
- Severe central nervous system diseases or pathological changes
- History of cancer within 5 years before signing the informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
N
Nan Shen, MD & PhD
CONTACT
H
Huihua Ding, MD
CONTACT
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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