2024-511293-74-01招募中1/2 期
Anti-CD19 CAR T-Cell TherApy in Refractory Systemic Autoimmune DISeases - CATARSIS
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年8月20日最近更新:
相关药物
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- - Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell Associated Neurotoxicity Syndrome (ICANS) within the first 4 weeks after ATMP administration. - Incidence and severity of infections and leukopenia and/or hypogammaglobulinemia during the entire study period.
研究概览
简要总结
To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc, DM/PM and AAV). To preliminarily assess the clinical efficacy of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc, DM/PM and AAV).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •General a) Subjects must understand and voluntarily sign an informed consent form including writ- ten consent for data protection; b) Adults aged ≥ 18 years and < 65 years at time of consent; c) Male subjects unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP; d) Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index <1) starting from the time of signing the ICF and for 12 months after dosing of the IMP; e) Must be able to adhere to the study visit schedule and other protocol requirements; f) Double vaccination (2 doses of vaccine)against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.
排除标准
- •Subjects having any of the following criteria at screening will not be included in the study: - Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator; - ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8 g/dl, absolute CD3+ T cell count ≤100/μl; - Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. - Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure or left ventricular ejection fraction < 50%, as determined by echocardiography - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study; - Impaired renal function, i.e., eGFR < 30 ml/min; - Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) < 40% of predicted or a Diffusing Capacity for Carbon Monoxide (DLCO) < 30% of predicted - Any concomitant severe active infection, including, HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody [HBcAb] or positive hepatitis B surface antigen [HBsAg] and NAT tests) and/or C (<12 weeks between achievement of a sustained virological response to the specific treatment and apheresis) according to the American Association for the Study of Liver Diseases guidelines, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment; - Pregnant or lactating females; - Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;; - Malignancy in the last 5 years before screening.The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed. - Previous CAR T cell administration; - A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1) and the medications permitted during the study (section 7.11); - Concurrent treatment with other investigational agents or participation in other investigational trials. - Treatment, as part of an investigational clinical trial, with an experimental product with definite or potential effect on T or B-cells in the previous 2 years. - Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis; - Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent; - Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results; - Subjects who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)
结局指标
主要结局
- Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell Associated Neurotoxicity Syndrome (ICANS) within the first 4 weeks after ATMP administration. - Incidence and severity of infections and leukopenia and/or hypogammaglobulinemia during the entire study period.
- Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell Associated Neurotoxicity Syndrome (ICANS) within the first 4 weeks after ATMP administration. - Incidence and severity of infections and leukopenia and/or hypogammaglobulinemia during the entire study period.
次要结局
- a) Duration of B cell depletion in the peripheral blood: CD19+ B cells assessed by fluorescence- activated cell sorting (FACS) equal to 0 up to week 24 and long-term FU. b) Duration of persistence of CAR T cells in the peripheral blood: CAR+ CD3+ cells assessed by FACS > 0 up to week 24 and long-term FU. c) Changes in the levels of disease-associated serum autoantibodies at week 24 including incidence of seroconversion (anti-dsDNA < LLN; ANA <1.100; all others “negative”) o SLE
研究者
Professoressa Maria Antonietta D'Agostino
Scientific
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (2)
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