Actively Recruiting
Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells
Led by Lingli Dong · Updated on 2024-02-26
24
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
L
Lingli Dong
Lead Sponsor
S
Shenzhen Pregene Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.
CONDITIONS
Official Title
Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old (including 70 years old)
- If kidneys involved, estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73 m2
- Absolute lymphocyte count of at least 0.5 x 10^9/L within 3 days before mononuclear cell collection
- Absolute neutrophil count of at least 1.0 x 10^9/L within 3 days before mononuclear cell collection
- Platelet count of at least 50 x 10^9/L without blood transfusion within 7 days before screening
- Hemoglobin level of at least 8.0 g/dL without red blood cell infusion within 7 days before screening
- Creatinine clearance rate or glomerular filtration rate of at least 30 mL/min
- Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN); higher bilirubin in Gilbert subjects allowed with sponsor consent
- AST and ALT levels less than or equal to 3 times ULN
- Plasma prothrombin time (PT), INR, and APTT less than or equal to 1.5 times ULN
- Willingness to sign informed consent form
- For refractory ANCA-associated vasculitis: diagnosed by 2022 ACR/EULAR criteria with active disease (BVAS score ≥3) and positive ANCA
- For refractory lupus nephritis: diagnosed by 2019 ACR criteria with active, proliferative LN confirmed by biopsy, positive ANA and/or anti-dsDNA, and SLEDAI-2000 score ≥8
- Estimated survival of at least 3 months
You will not qualify if you...
- Pregnant or lactating women
- Requiring invasive pulmonary ventilation due to alveolar hemorrhage
- Having other autoimmune diseases involving multiple organs besides diagnosed condition
- Severe extrarenal lupus manifestations or other autoimmune diseases besides SLE
- Known allergies or severe reactions to PRG-1801 components or related drugs
- History of malignant tumors within past 5 years except certain removed skin or cervical cancers
- Significant cardiovascular disease including recent heart events or severe heart failure
- Recent treatment with B cell depletion, biological agents, immunosuppressants, plasma exchange, or IVIG within specified timeframes
- Vaccination with live or attenuated vaccines within 4 weeks before or during study
- Chronic active infections such as hepatitis B, C, HIV, or syphilis
- Active infections requiring intravenous antibiotics or hospitalization
- Major surgery within 4 weeks before enrollment
- Serious uncontrolled comorbidities that could interfere with study
- Participation in other intervention trials within 3 months or 5 drug half-lives
- Other conditions deemed unsuitable for lymphocyte clearance or cell infusion by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Lingli Dong, MD
CONTACT
C
Cong Ye, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here