Universal CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Apr 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CHT101, a type of cell therapy, for patients with systemic lupus erythematosus (SLE) who have not responded to standard treatments or have experienced a relapse of their disease. The main goal is to see how safe and effective this therapy is in helping manage SLE symptoms. The trial is still in the early stages and has not started recruiting participants yet.

To be eligible for this study, participants must be between 18 and 65 years old and meet specific criteria showing they have SLE. This includes having certain scores that indicate the severity of their condition and a history of not responding well to common treatments like steroids and other medications. Participants will need to agree to follow certain health guidelines during the study and provide informed consent. This means they will be fully aware of what the study involves before participating. If you or someone you know fits these criteria and is interested in a new treatment option for lupus, this trial could be an opportunity to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
• • 2. SLEDAI-2000 score \>6.
• • 3. Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
• • 4. Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for \>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
• • 5. Aged 18-65 years; both genders eligible.
• • 6. Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹/L. Absolute neutrophil count ≥1×10⁹/L (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g/L; Liver function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.
• • 7. Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.
• • 8. Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.
• Exclusion Criteria:
• • 1. Presence of neuropsychiatric lupus (NPSLE).
• • 2. History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
• • 3. History of severe drug allergies or hypersensitivity.
• • 4. Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
• • 5. Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
• • 6. Severe cardiac diseases.
• • 7. Congenital immunoglobulin deficiency.
• • 8. History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival \>5 years).
• • 9. End-stage renal failure.
• • 10. Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).
• • 11. Psychiatric disorders or severe cognitive impairment.
• • 12. Participation in other clinical trials within 3 months prior to enrollment.
• • 13. Pregnant women or those planning pregnancy.
• • 14. Other conditions deemed by the investigator to preclude study participation.