About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CAR-T Therapy
Treatment groups
Sponsors and collaborators
Beijing GoBroad Hospital
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator