Actively Recruiting
Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Led by Changhai Hospital · Updated on 2026-02-25
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with relapsed or refractory autoimmune diseases. This early phase 1, single-arm, open-label pilot study plans to enroll 60 patients to understand how this treatment works in conditions such as systemic lupus erythematosus, systemic sclerosis, primary Sjögren syndrome, rheumatoid arthritis, and anti-neutrophil cytoplasmic antibody-associated vasculitis. Participants will receive a dose-escalation treatment with anti-CD19/BCMA CAR T cells called KN3601. Before the CAR T cell infusion, patients will be given Fludarabine and Cyclophosphamide on days -5, -4, and -3. The study will monitor the effects of a single-dose injection of these CAR T cells over a 52-week period following infusion. During the study, participants will be closely observed for dose-limiting toxicities and treatment-emergent adverse events up to 52 weeks after infusion. Researchers will also measure overall response rates, disease control rates, B cell depletion and recovery. Patients will undergo regular assessments and follow-ups throughout the study period to track safety and treatment impact, with the total observation lasting up to one year after treatment.
CONDITIONS
Brief Title
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, male or female
- Adequate organ function including neutrophil count ≥ 1 x 10^9/L and hemoglobin ≥ 60 g/L
- Liver function: ALT ≤ 3 times upper limit of normal (ULN), AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN
- Coagulation: INR ≤ 1.5 x ULN, prothrombin time ≤ 1.5 x ULN
- Cardiac function: stable, left ventricular ejection fraction ≥ 50%
- Use of approved contraception or abstinence for those of childbearing potential during and 6 months after treatment
- Negative pregnancy test within 7 days before enrollment for females of childbearing potential
- Voluntary participation with informed consent and compliance
- Diagnosis of relapsed/refractory systemic lupus erythematosus meeting classification criteria and disease activity scores
- Diagnosis of relapsed/refractory systemic sclerosis with specific lung involvement and treatment history
- Diagnosis of relapsed/refractory primary Sjögren's syndrome with disease activity and treatment history
- Diagnosis of relapsed/refractory rheumatoid arthritis meeting classification and disease activity criteria
- Diagnosis of relapsed/refractory ANCA-associated vasculitis with positive antibodies and disease activity
You will not qualify if you...
- Known severe allergic reactions or contraindications to study medications
- Uncontrolled or treatable infections
- Central nervous system disorders including epilepsy or psychiatric illnesses
- Serious heart diseases such as angina, heart failure, or arrhythmia
- Congenital immunoglobulin deficiency
- Malignant tumors except certain skin and cervical, bladder, breast cancers disease-free for over 5 years
- End-stage renal failure
- Positive for hepatitis B, C, HIV, or syphilis infections
- Severe mental illness or cognitive impairment
- Participation in other clinical trials within 6 months
- Pregnant or intending to conceive women
- Uncontrolled hypertension or diabetes
- Other medical conditions preventing study inclusion as judged by investigator
- Additional disease-specific exclusions including significant organ disorders, active skin diseases, liver cirrhosis, myelodysplastic syndromes, severe rheumatoid arthritis functional status, and severe kidney impairment requiring ventilation
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.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive lymphodepleting chemotherapy followed by a single dose injection of anti-CD19/BCMA Universal CAR-T cells to treat relapsed/refractory autoimmune diseases.
1 baseline visit and multiple visits during the first week
Duration - Up to 52 weeks after infusion
Participants are monitored for safety and efficacy outcomes, including dose-limiting toxicities and treatment emergent adverse events, for up to 52 weeks after infusion.
Weekly visits for the first month, then monthly visits up to 52 weeks
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Dongbao Zhao
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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