NCT06822881
CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
Recruiting · Phase 1 · Beijing GoBroad Hospital · registry updated 2026-03-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
Inclusion
- Voluntary signing of the Informed Consent Form (ICF)
- Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
- No systemic active infection within 2 weeks before screening.
- Contraceptive requirements for participants with child - bearing potential.
- Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE
- Meet the EULAR/ACR 2019 SLE classification criteria with a disease history ≥ 6 months.
Exclusion
- Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
- Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
- Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.
- Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
- Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
- Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.