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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is focused on patients with active autoimmune diseases including Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies (IIM), and Sjogren's Syndrome (pSS). The study aims to evaluate the safety, tolerability, how the body processes and responds to, and the effectiveness of two types of CAR-T therapies targeting CD19 or CD19-BCMA in these conditions. This early phase 1 trial is sponsored by Nanjing Bioheng Biotech Co., Ltd and involves patients aged between 18 and 70 years. Participants will receive CAR T-cell therapy administered through an intravenous infusion following a lymphodepleting chemotherapy regimen that includes fludarabine and cyclophosphamide. The study includes one experimental treatment group receiving CD19 or CD19-BCMA CAR-T cells. The trial is open-label with no masking or placebo control. During the study, participants will be closely monitored for adverse events related to the treatment over a period of two years. Assessments include laboratory tests for liver, kidney, blood counts, coagulation, oxygen levels, and heart function. Female participants of childbearing potential must undergo pregnancy testing and use contraception. The main outcome measured is the incidence of treatment-emergent and serious adverse events. Participant safety and treatment effects will be carefully evaluated throughout the trial period which starts in September 2024 and may continue until the end of 2027.
CONDITIONS
Brief 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 signed informed consent to participate in the study
- Age between 18 and 70 years old, any sex
- Liver function with ALT and AST less than or equal to 3 times the upper limit of normal, and total bilirubin less than or equal to 2 times the upper limit of normal (except Gilbert's syndrome)
- Renal function with creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance at least 40 ml/min
- Blood counts: neutrophils at least 1 x 10^9/L, hemoglobin at least 60 g/L, platelets at least 20 x 10^9/L, lymphocytes greater than 0.3 x 10^9/L
- Coagulation with INR or prothrombin time less than or equal to 1.5 times the upper limit of normal
- Oxygen saturation at rest at least 92% on room air
- Left ventricular ejection fraction at least 50% on echocardiography
- Negative serum or urine pregnancy test for females of childbearing potential at screening
- Women of childbearing potential agree to use highly effective contraception from 28 days before treatment until 12 months after CAR-T reinfusion
- Men of childbearing potential agree to use effective barrier contraception from lymphodepleting therapy initiation until 12 months after CAR-T reinfusion and refrain from donating semen throughout the trial
- SLE patients diagnosed by 2019 EULAR/ACR or 2012 SLICC criteria with positive ANA, anti-dsDNA, or anti-Smith antibodies and SLEDAI-2K score greater than 6 and clinical score at least 4 at screening
- SSc patients diagnosed by 2013 ACR/EULAR criteria with diffuse cutaneous SSc and disease duration up to 6 years
- AAV patients meeting 2022 ACR/EULAR criteria with positive MPO-ANCA or PR3-ANCA antibodies
- IIM patients diagnosed by 2017 ACR/EULAR criteria with active disease defined by abnormal muscle strength, physician and patient global assessments, extramuscular activity, HAQ score, and CK enzyme levels
- Sjogren's Syndrome patients diagnosed by 2016 ACR/EULAR criteria with positive anti-SSA/Ro antibodies and ESSDAI score of at least 5 at screening
You will not qualify if you...
- SLE patients with uncontrolled lupus crisis within 8 weeks before screening including severe organ involvement assessed unsuitable by investigator
- IIM patients with severe rhabdomyolysis or creatine kinase levels 120 times the upper limit of normal at screening
- Severe asthma or COPD patients are eligible; mild or moderate patients on stable treatment can enroll
- Active infection requiring systemic treatment within 2 weeks prior to urethral irrigation
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA; positive for hepatitis C antibody with detectable RNA; positive for HIV or syphilis antibodies
- Pregnant or breastfeeding women
- Any condition that may affect participation, pose safety risks, or confound study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of active treatment as per protocol
Participants receive CD19 or CD19-BCMA CAR-T cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
1 treatment visit with CAR-T infusion plus lymphodepleting therapy
Duration - Up to 2 years
Participants are monitored for adverse events and safety for up to 2 years after treatment.
Visits for safety monitoring during follow-up period
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
M
Ming Gao
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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