NCT06946485 Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
| NCT ID | NCT06946485 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Systemic Lupus Erythematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-04-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Lingyun Sun
STUDY CHAIR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Frequently Asked Questions
Who can join the NCT06946485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06946485 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06946485 currently recruiting?
Yes, NCT06946485 is actively recruiting participants. Contact the research team at xjtang09@163.com for enrollment information.
Where is the NCT06946485 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06946485 clinical trial?
NCT06946485 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Lingyun Sun at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 15 participants.
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