NCT07558850
Recruiting
Not Applicable
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country72 target enrollmentStarted: May 10, 2026Last updated:
Interventionsanti-CD19/BCMA-UCAR-T cells
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of Dose-Limiting Toxicity (DLT)
Overview
Brief Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases.
36-72 patients are planned to be enrolled in the dose-escalation trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Common Inclusion Criteria
- •Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.
- •Aged 18 to 70 years, regardless of gender.
- •At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \> 5 cells/μL.
- •For subjects previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at the screening visit.
- •Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD):
- •Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L Hemoglobin (Hb) ≥ 80 g/L Platelet count (PLT) ≥ 50×10⁹/L
- •Subjects have adequate hepatic, renal, pulmonary and cardiac function at screening visit, defined as:
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) Total bilirubin (TBIL) ≤ 1.5 × ULN; except for patients with Gilbert syndrome, whose TBIL must be ≤ 3.0 × ULN Renal function: estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m². Subjects with eGFR \< 30 mL/min/1.73m² and/or receiving renal replacement therapy may be enrolled if the investigator assesses benefits outweigh risks and full informed consent is obtained from the subject or guardian.
- •Peripheral oxygen saturation (SpO₂) ≥ 92% under room air without oxygen supplementation; no clinically significant pleural effusion (excluding that related to the target indication).
Exclusion Criteria
- •Common Exclusion Criteria
- •History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ with a disease-free interval of at least 5 years post resection), or concurrent malignant tumors.
- •Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen therapy via oxygen reservoir mask, non-invasive or invasive mechanical ventilation support at screening.
- •Known allergy, hypersensitivity, intolerance or contraindication to CD19/BCMA CAR-NK cells or any investigational medicinal ingredients (including fludarabine, cyclophosphamide and tocilizumab), or history of severe anaphylactic reactions.
- •Evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection at screening or baseline visit.
- •Cardiac insufficiency classified as NYHA Class Ⅲ or Ⅳ according to New York Heart Association criteria (see Appendix).
- •Congenital heart disease prior to screening, history of acute myocardial infarction within 6 months, severe arrhythmia (including multifocal frequent supraventricular tachycardia, ventricular tachycardia, etc.), moderate to massive pericardial effusion, severe myocarditis; unstable vital signs requiring vasopressor support.
- •Active or uncontrolled infection requiring parenteral antimicrobial therapy at screening or baseline visit.
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral HBV DNA level above upper limit of normal; positive HCV antibody with peripheral HCV RNA level above upper limit of normal; positive HIV antibody, positive syphilis serology, or positive cytomegalovirus (CMV) DNA.
- •History of severe herpes infection such as herpes encephalitis, ocular herpes or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella and herpes zoster) within 12 weeks prior to screening.
Arms & Interventions
KN3601
Experimental
Intervention: anti-CD19/BCMA-UCAR-T cells (Biological)
Outcomes
Primary Outcomes
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: up to 48 weeks after infusion
To characterize the safety of anti-CD19/BCMA-UCAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: up to 48 weeks after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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