Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases

NCT07558850 | Recruiting

• 1 other identifier: 2026-SR-020
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Systemic Lupus Erythematosus; Dermatomyositis; Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicity (DLT)

  To characterize the safety of anti-CD19/BCMA-UCAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases

  up to 48 weeks after infusion

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases

  up to 48 weeks after infusion

Study Arms (1)

KN3601

EXPERIMENTAL

Biological: anti-CD19/BCMA-UCAR-T cells

Interventions

anti-CD19/BCMA-UCAR-T cells BIOLOGICAL

Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of anti-CD19/BCMA CAR T cells (KN3601) will infused using dose-escalation strategy.

KN3601

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Left ventricular ejection fraction (LVEF) ≥ 50%; no pericardial effusion confirmed by echocardiography (excluding indication-related effusion); no clinically significant abnormalities on electrocardiogram (ECG).
• During the screening period, serum pregnancy test must be negative for fertile female subjects. Females who have undergone surgical sterilization or natural menopause for at least 2 years are considered non-fertile. Fertile female and male subjects must adopt highly effective contraceptive methods throughout the clinical study and for 1 year after the last study treatment. They shall also agree not to donate oocytes or sperm for assisted reproductive technology within 1 year following the final study treatment.
• Relapsed/Refractory Rheumatoid Arthritis (RA)
• Meet the 2010 ACR/EULAR classification diagnostic criteria, diagnosed with moderate to severe active rheumatoid arthritis, with a confirmed RA diagnosis for ≥ 6 months.
• Swollen joint count ≥ 6 (based on 66-joint assessment) and tender joint count ≥ 6 (based on 68-joint assessment) at screening.
• C-reactive protein (CRP) ≥ 10 mg/L or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h at screening.

You may not qualify if:

• 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.
• Active tuberculosis, history of active tuberculosis, or negative interferon-gamma release assay for tuberculosis infection not achieved during screening period.
• History of epilepsy or other active central nervous system disorders.
• Subjects with acquired or congenital immunodeficiency diseases.
• Any clinically significant cardiac, endocrine, hematological, hepatic, immune, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal disorders or major medical history that may interfere with KN3601 administration, as judged by the investigator.
• Solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; acute graft-versus-host disease (GVHD) Grade ≥2 within 2 weeks prior to screening.
• Administration of live vaccines within 4 weeks prior to screening.

Sponsors & Collaborators

• Rui Therapeutics Co., Ltd: collaborator
• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Dermatomyositis; Lupus Erythematosus, Systemic; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases

Central Study Contacts

Wenfeng Tan

CONTACT

13770769608; Tanwenfeng2005@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)