Universal anti-CD70 CAR-T (CHT101) treatment for relapsed, treatment-resistant systemic lupus (SLE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open-label, single-arm early Phase 1 trial testing a universal (allogeneic) anti-CD70 CAR-T product (CHT101) in adults with relapsed, refractory SLE. Eligible participants meet defined activity thresholds (SLEDAI-2000 >6 and BILAG criteria) and prior-treatment failure, then receive CHT101 and are followed closely for safety and clinical response. The primary focus is on short-term safety and tolerability, with secondary measures including changes in disease activity scores and steroid-sparing effects. Results will inform dose selection and the design of future larger trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaojun Tang
• Email: xjtang09@163.com
• Phone: 18021397168

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.