Clinical trial NCT06946485: Universal CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
Official title: A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus (SLE)
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigator-initiated trial aims to evaluate the safety and efficacy of 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 CHT101 in patients with relapsed refractory systemic lupus erythematosus.

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.

Primary outcomes:
measure: SRI-4 Response
timeFrame: SRI-4 response at 1 month after CHT101 infusion.
measure: Safety Evaluation
timeFrame: safety evaluation Within 12 months after CHT101 infusion.
Secondary outcomes:
measure: Disease Activity Index
timeFrame: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
measure: Organ Damage
timeFrame: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
measure: BILAG 2004
timeFrame: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
measure: Overall assessment of physicians
timeFrame: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Lingyun Sun
role: STUDY_CHAIR
References: