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Search / Trial NCT07052565

CAR-T Cells Therapy for Patients With Autoimmune Diseases

Launched by ANHUI PROVINCIAL HOSPITAL · Jun 26, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Systemic Sclerosis Dry Syndrome Rheumatoid Arthritis Systemic Lupus Erythematosus

ClinConnect Summary

This clinical trial is studying a new treatment called CAR-T cell therapy for people with autoimmune diseases that have not responded well to other treatments. CAR-T therapy uses specially modified immune cells to target and help control the faulty immune response causing the disease. The goal of this study is to see if the treatment is safe and if it helps improve symptoms in patients with conditions like rheumatoid arthritis, lupus, Sjögren’s syndrome, or systemic sclerosis.

Adults aged 18 and older who have active autoimmune disease despite trying standard treatments might be eligible to join. Participants need to meet certain health requirements, such as having a stable blood count and kidney function, and must have a confirmed diagnosis of one of the autoimmune diseases mentioned. People with serious infections, certain other health problems, or who are pregnant are not eligible. If you join the study, you will receive the CAR-T cell therapy and be closely monitored to see how well it works and to check for any side effects. This study is currently recruiting participants at one site and aims to include up to 18 people.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
  • (2) Bone marrow hematopoietic function satisfies: white blood cell count≥3×10\^9/L; Centrocyte count ≥1×10\^9/L (no colony-stimulating factor received within 2 weeks prior to screening); Hemoglobin ≥ 60g/L.
  • (3)ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN。 (4) Renal function satisfaction: creatinine clearance CrCl≥30mL/min. (5) INR≤1.5×ULN , PT≤1.5×ULN. (6)RA:Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ; 3 months after use of 1 or more csDMARDs and 1 or more bDMARDs prior to screening: 1) DAS28-ESR\>3.2 or CDAI\>10; or 2) the dose of the hormone (prednisone or equivalent) cannot be reduced to less than 7.5 mg/day; or 3) the number of swollen and/or tender joints ≥3; Treatment with stable 1 or more cs DMARD(s) and/or bDMARDs prior to enrollment as follows: methotrexate for at least 12 weeks and at a dose of 7.5-25mg/week for at least 4 weeks; Stable use of hydroxychloroquine dose ≤ 400 mg/day for at least 4 weeks; Stable oral sulfasalazine for at least 4 weeks 1\~3 g/d; Stable oral leflunomide 10-20 mg/day for at least 4 weeks.
  • (7)systemic lupus erythematosus : Diagnosis of systemic lupus erythematosus according to the SLE classification criteria of the 2019 EULAR/ACR; History of systemic lupus erythematosus for at least 6 months prior to screening and active disease for 2 months after use of standard treatment regimens prior to screening; BILAG-2004 assesses the presence of at least 1 Grade A or 2 Grade B organ scores; Positive antinuclear antibody, or positive anti-ds-DNA antibody, or positive anti-Sm antibody; SLEDAI-2000 score ≥8 during the screening period.
  • (8)Sjögren's syndrome : Diagnosis of Sjögren's syndrome according to the 2002 International Classification of Primary Sjögren's Syndrome or the 2016 ACR/EULAR classification criteria; Diagnosed with pSS-TP and platelet count \< 30×10\^9/L; Sjögren's syndrome Disease Activity Index (ESSDAI) score ≥5 during the screening period; Sjögren's syndrome for at least 6 months prior to screening and active disease 2 months after use of conventional treatment regimens prior to screening. Use of immunomodulatory drugs for more than 6 months.
  • (9)systemic sclerosis : Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis. Positive antinuclear antibody at screening. Presence of clear evidence of HRCT progression. History of systemic sclerosis prior to screening for at least 6 months and active disease for 2 months after use of conventional treatment regimens prior to screening.
  • Exclusion Criteria:
  • (1) Clinically significant central nervous system diseases or pathological changes not caused by the disease itself before screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or mental disorder.(2) Those with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia.(3) History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.(4) Vaccination, B-cell targeted therapy within 4 weeks prior to screening.(5) History of any malignant neoplastic disease.(6) Patients with end-stage renal failure.(7) The presence or suspicion of uncontrollable fungal, bacterial, viral, or other infections.(8) History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.(9) Patient has active HBV infection or HCV antibody positivity or HIV antibody positivity or syphilis positivity or CMV DNA positivity or EBV DNA positivity.(10) Pregnant or lactating females, or planning to become pregnant within 2 years after reinfusion of the trial drug; The partner of the male patient plans to become pregnant within 2 years of receiving the trial drug.(11) Evidence of active tuberculosis infection.(12) Other conditions assessed by the investigator as unsuitable for enrollment.

About Anhui Provincial Hospital

Anhui Provincial Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to enhance patient outcomes and contribute to the global body of medical knowledge. With a focus on translating research findings into practical applications, Anhui Provincial Hospital is dedicated to fostering collaboration among healthcare professionals and researchers, ensuring that cutting-edge treatments and interventions are accessible to the communities it serves.

Locations

Hefei, , China

Patients applied

0 patients applied

Trial Officials

wang xing bing, M.D

Principal Investigator

Anhui Provincial Hospital

chen zhu, M.D

Principal Investigator

Anhui Provincial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported