A clinical study exploring the safety, efficacy, and cellular metabolic kinetics of universal CD19/20 CAR-T cell injection in anti neutrophil cytoplasmic antibody associated vasculitis.
This study is a single arm, open label, exploratory dose escalation clinical trial aimed at evaluating the safety, efficacy, and cellular metabolic dynamics of CT1192 cells in patients with ANCA associated vasculitis.
ANCA associated vasculitis that meets the 2022 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria, including microscopic polyangitis, granulomatous polyangitis, and eosinophilic granulomatous polyangitis;
Voluntarily sign the Informed Consent Form (ICF）; When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;
No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal dialysis to 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use effective barrier contraception methods from the start of lymphatic dialysis until 1 year after CT1192 reinfusion, and should not donate semen or sperm throughout the entire study period;
Previously received CAR-T cell or other genetically modified T cell therapy, or had a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
Screening for CD20 monoclonal antibodies such as rituximab used within the previous 6 months;
Use other biological agents such as Mabolizumab during the screening period of 12 weeks;
Allergic or intolerant reactions to Qinglin drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1192 preparations or their excipients (including dimethyl sulfoxide (DMSO)), or previous history of other severe allergies such as anaphylactic shock;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator