Status:
RECRUITING
Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.
Detailed Description
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lup...
Eligibility Criteria
Inclusion
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
- SLEDAI-2000 score \>6.
- Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
- 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).
- Aged 18-65 years; both genders eligible.
- 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%.
- 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.
- Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.
Exclusion
- Presence of neuropsychiatric lupus (NPSLE).
- History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
- History of severe drug allergies or hypersensitivity.
- Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
- Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
- Severe cardiac diseases.
- Congenital immunoglobulin deficiency.
- History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival \>5 years).
- End-stage renal failure.
- 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).
- Psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior to enrollment.
- Pregnant women or those planning pregnancy.
- Other conditions deemed by the investigator to preclude study participation.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06946485
Start Date
April 1 2025
End Date
March 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China