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)
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.
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.
Single group
CAR-T Therapy
DrugCT1190B cells infusion
The incidence rate and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern)
Proportion of patients who reach lupus low disease activity status (LLDAS) 6 months after infusion
Changes in American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) compared to baseline after 3 months of infusion
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Beijing GoBroad Hospital
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator
