Actively Recruiting
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
Led by Nanjing Bioheng Biotech Co., Ltd. · Updated on 2026-03-06
20
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.
CONDITIONS
Official Title
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 70 years, any gender
- Liver function: ALT and AST no more than 3 times upper normal limit; total bilirubin no more than 2 times upper normal limit (except Gilbert's syndrome)
- Renal function: creatinine no more than 1.5 times upper normal limit or creatinine clearance at least 40 ml/min
- Blood counts: neutrophils at least 1.0 x10^9/L, hemoglobin at least 60 g/L, platelets at least 20 x10^9/L, lymphocytes above 0.3 x10^9/L
- Coagulation: INR or prothrombin time no more than 1.5 times upper normal limit
- Oxygen saturation at rest at least 92% on room air
- Left ventricular ejection fraction at least 50% on echocardiography
- Negative pregnancy test for women of childbearing potential at screening
- Women of childbearing potential must use highly effective contraception from 28 days before treatment to 12 months after CAR-T reinfusion
- Men of childbearing potential must use effective barrier contraception from lymphodepletion until 12 months after CAR-T reinfusion and avoid semen donation during the trial
- For SLE: definitive diagnosis by 2019 EULAR/ACR or 2012 SLICC criteria; positive ANA and/or anti-dsDNA and/or anti-Smith antibodies; SLEDAI-2K score above 6 and clinical score at least 4
- For SSc: diagnosis by 2013 ACR/EULAR criteria; diffuse cutaneous form with disease duration 6 years or less
- For AAV: diagnosis by 2022 ACR/EULAR criteria including MPA, GPA, or EGPA; positive ANCA antibodies within 3 months before or at screening
- For IIM: diagnosis by 2017 ACR/EULAR criteria with at least probable diagnosis; active disease with at least 2 abnormal core set measures including muscle strength, global assessments, extramuscular activity, HAQ, or CK levels
- For Sjogren's Syndrome: diagnosis by 2016 ACR/EULAR criteria; positive anti-SSA/Ro antibodies within 3 months before or at screening; ESSDAI score at least 5
You will not qualify if you...
- For SLE: uncontrolled lupus crisis within 8 weeks prior to screening including severe organ involvement deemed unsuitable by the investigator
- For IIM: severe rhabdomyolysis or creatine kinase levels above 120 times upper normal limit at screening
- Active infections requiring systemic treatment within 2 weeks prior to screening such as pneumonia or tuberculosis
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody with detectable virus, hepatitis C antibody with detectable RNA, HIV antibody, or syphilis antibody
- Pregnant or breastfeeding women
- Any condition judged by the investigator to affect safety or study participation or confound results
- Patients with severe asthma or COPD are eligible; those with mild or moderate asthma or COPD on stable treatment may also enroll
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third the People's Hospital of Bengbu
Bengbu, Anhui, China, 233000
Actively Recruiting
Research Team
P
Peng Yu
CONTACT
M
Ming Gao
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