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

A Clinical Study of the Safety and Efficacy of Universal Anti-CD70 CAR-T (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus

This trial will try a universal anti-CD70 CAR-T cell therapy (CHT101) in adults with relapsed or treatment-resistant systemic lupus (SLE).

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other)
• Drugs / interventions: rituximab, belimumab, methotrexate, cyclophosphamide, CAR-T
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06946485 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 with SLE by 2019 EULAR/ACR criteria who have active disease (SLEDAI-2000 >6, at least one BILAG A or two B scores) and have failed conventional immunosuppressive and biologic therapies are the intended participants.

Not a fit: Patients with mild or inactive SLE (SLEDAI ≤6), outside the 18–65 age range, with inadequate organ function, or who cannot undergo cell therapy procedures are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, CHT101 could offer a new option that induces durable disease control and reduces the need for high-dose immunosuppression in patients with refractory SLE.

How similar studies have performed: CAR-T therapies targeting B-cell antigens (e.g., CD19) have shown promising early signals in autoimmune diseases including individual SLE cases, but anti-CD70 CAR-T for SLE is a novel approach with limited prior clinical data.

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.

Where this trial is running

Nanjing, Jiangsu

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xiaojun Tang

Conditions: Systemic Lupus Erythematosus