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;
Single group
CAR-T Therapy
Biological/VaccineCT1192 cells infusion
Evaluate the safety and tolerability of CT1192 in patients with ANCA associated vasculitis
The incidence and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern);
Evaluate the maximum tolerable dose (MTD) and/or dose range of CT1192
CT1192 MTD and/or dose range
After treatment, the Birmingham vasculitis activity score (bvas) changed from baseline
Preliminary evaluation of the effectiveness of CT1192 in patients with ANCA related vasculitis. Changes in Birmingham vasculitis activity score (BVAS) compared to baseline at 3 months and other time points (1, 6, 9, and 12 months) after medication.
Changes of vasculitis damage index (VDI) from baseline after medication
Preliminary evaluation of the effectiveness of CT1192 in patients with ANCA related vasculitis. Vasculitis damage index (VDI) and changes from baseline at 3 months and other time points (1, 6, 9, and 12 months) after medication.
Changes of serum markers (MPO-ANCA or PR3-ANCA) in ANCA related vasculitis after medication
Preliminary evaluation of the effectiveness of CT1192 in patients with ANCA related vasculitis. Changes in serum markers of ANCA related vasculitis (MPO-ANCA or PR3-ANCA) levels at 1, 3, 6, 9, and 12 months after medication.
Changes of immunoglobulin (IgG, IgM, IgA, IgE) levels after medication
Preliminary evaluation of the effectiveness of CT1192 in patients with ANCA related vasculitis. Changes in immunoglobulin (IgG, IgM, IgA, IgE) levels at 1, 3, 6, 9, and 12 months after medication.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
