Actively Recruiting
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
Led by Nanjing Bioheng Biotech Co., Ltd. · Updated on 2025-10-02
84
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).
CONDITIONS
Official Title
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Aged 18 years and older but no more than 75 years.
- Adequate organ function including bone marrow, liver, coagulation, and pulmonary function as specified.
- Female participants of childbearing potential must have a negative pregnancy test.
- Use of highly effective contraception by female participants of childbearing potential and male participants with partners of childbearing potential from consent until 6 months after treatment.
- For Anti-GBM disease: Positive anti-GBM antibody and evidence of renal involvement with active, biopsy-confirmed disease.
- For SLE/LN: Diagnosis per specified criteria, positive relevant antibodies, and SLEDAI-2K score over 6.
- For AAV/AAGN: Diagnosis per criteria, positive ANCA antibodies, and active vasculitis with BVAS score 3 or higher if no renal involvement.
- For MN: Biopsy-confirmed primary membranous nephropathy with high-risk or relapsed/refractory status.
- For SSc: Diagnosis of diffuse cutaneous systemic sclerosis per criteria.
- For IIM: Diagnosis per criteria including dermatomyositis, anti-synthetase syndrome, or immune-mediated necrotizing myopathy.
You will not qualify if you...
- For SLE/LN: Severe active CNS lupus or drug-induced/secondary lupus.
- For AAV/AAGN: Drug-induced/secondary forms and alveolar hemorrhage needing invasive ventilation.
- For Anti-GBM disease: Anuria over 7 days, dialysis dependence over 30 days, moderate/severe pulmonary hemorrhage, symptomatic congestive heart failure requiring medication.
- For MN: Secondary membranous nephropathy.
- For IIM: Severe rhabdomyolysis or extremely elevated creatine kinase levels.
- For SSc: Recent scleroderma renal crisis, cardiac tamponade, active digital ulcer infection, or presence of digital gangrene.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bioheng Study site
Shanghai, China
Actively Recruiting
Research Team
P
Peng Yu
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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