Actively Recruiting
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Led by Changhai Hospital · Updated on 2025-08-29
72
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases that have relapsed or are resistant to treatment. This open-label pilot study plans to enroll between 36 and 72 patients to evaluate both the safety and feasibility of this cell therapy. The study also aims to assess how well the treatment works in controlling disease activity. Participants will receive a combination of Fludarabine and Cyclophosphamide chemotherapy drugs on days -5, -4, and -3 before receiving multiple doses of CD19 CAR NK cells. The treatment follows a dose-escalation strategy to carefully increase the cell dose. This trial is a single-arm study without a comparison group, focusing on patients with relapsed or refractory autoimmune diseases. During the study, participants will be closely monitored for up to 48 weeks after infusion to track side effects and treatment-related toxicities. Researchers will assess response rates and disease control at several time points up to 12 months after treatment. Patients will have regular evaluations including blood tests and clinical assessments to measure safety and treatment impact over time.
CONDITIONS
Brief Title
An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, male or female
- Adequate bone marrow function: white blood cell count ≥ 3 x 10^9/L, neutrophil count ≥ 1 x 10^9/L, hemoglobin ≥ 60 g/L
- Liver function within limits: ALT ≤ 3 x ULN, AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (with exceptions for Gilbert syndrome)
- Renal function: creatinine clearance ≥ 60 ml/min
- Coagulation function: INR < 1.5 x ULN, prothrombin time < 1.5 x ULN
- Good cardiac function and hemodynamic stability
- Use medically approved contraception or abstain from sex for at least 6 months during and 6 months after study if of childbearing potential
- Negative serum HCG test within 7 days before enrollment for females of childbearing potential; not lactating
- Voluntary participation with signed informed consent and compliance with follow-up
- Specific diagnostic criteria and disease activity requirements for relapsed refractory dry syndrome, systemic sclerosis, idiopathic inflammatory myopathy, and rheumatoid arthritis as detailed in protocol
- History of ineffective conventional treatment or relapse after remission with specified immunomodulatory drugs for at least 6 months
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to cyclophosphamide, fludarabine, tozumabs, or other study medications
- Active or uncontrolled fungal, bacterial, viral, or other infections requiring treatment
- Central nervous system disorders including epilepsy, psychosis, encephalopathy, stroke, encephalitis, or CNS vasculitis
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunodeficiency diseases
- Malignant tumors except certain skin, cervical, bladder, or breast cancers disease-free for over 5 years
- End-stage renal failure
- Positive hepatitis B, hepatitis C, HIV, or syphilis tests with active infection
- Mental illness or severe cognitive impairment
- Participation in another clinical trial within last 3 months
- Pregnant or intending to conceive women
- Additional disease-specific exclusions such as liver cirrhosis, aplastic anemia, drug-induced myositis, inclusion body myositis, tumor-associated myositis, and rheumatoid arthritis functional status grade 4
- Other investigator-determined reasons preventing study inclusion
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 - Preparative chemotherapy on days -5 to -3; CAR NK cell infusions follow thereafter
Participants receive preparative chemotherapy followed by multiple doses of CD19 CAR NK cell infusions using a dose-escalation strategy.
Several visits for chemotherapy and multiple infusions
Duration - Up to 48 weeks after infusion
Participants are monitored for safety and treatment response for up to 48 weeks after infusion.
Regular visits throughout the follow-up period
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Dongbao Zhao, Dr
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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