KCT0009580尚未招募Unknown
Phase 2a, open-label, multi-center study of GI-101A or GI-102 (CD80-IgG4 FC-IL2v) in patients with relapsed/refractory diffuse large B-cell lymphoma following anti-CD19 chimeric antigen receptor T-cell therapy (CARNATION)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Male and female adults aged 19 years or older.
- •Histologically confirmed DLBCL based on the WHO classification 2017.
- •Relapsed or refractory DLBCL after 2 or more lines of systemic therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2.
- •Adequate hematological, renal, hepatic, pulmonary, cardiac, and bone marrow function confirmed within 2 weeks prior to screening:
- •A. Hematological function:
- •i. Absolute neutrophil count = 1,000/µL.
- •ii. Platelet count = 75,000/µL.
- •B. Renal function: Glomerular filtration rate (eGFR)* = 40 mL/min/1.73m².
- •C. Hepatic function:
- •i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN) (or = 5 × ULN in the presence of liver metastases).
- •ii. Total bilirubin = 2.0 mg/dL (or = 3.0 × ULN in Gilbert's syndrome, with direct bilirubin = 1.5 × ULN).
- •D. Cardiac function: Left ventricular ejection fraction (LVEF) = 40% confirmed by echocardiogram (ECHO) or MUGA scan.
- •Life expectancy of at least 12 weeks.
- •In fertile women, confirmation of negative clinical pregnancy test (serum or urine hCG) during the screening period of this clinical trial.
- •Voluntary participation in this clinical trial with written informed consent.
排除标准
- •1) Individuals with a history of prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- •2) Individuals with the following comorbidities that may impact safety and efficacy evaluation during the clinical trial period, as determined by the investigator:
- •A. Severe infections or other active infectious diseases requiring systemic antibiotics or antiviral agents during the clinical trial period, which may impact safety and efficacy evaluation.
- •B. Conditions requiring corticosteroid therapy or autoimmune diseases (except for physiologic corticosteroid replacement therapy).
- •C. Other uncontrolled or clinically significant comorbidities that would deem participation in the clinical trial inappropriate.
- •3) Individuals with the following medical history at the screening visit:
- •A. Clinically significant cardiac disorders within 6 months before screening, including unstable angina, myocardial infarction, cardiac angioplasty, stent placement, or other clinically significant cardiac conditions.
- •B. Clinically significant thromboembolic disease, pulmonary embolism, or bleeding diatheses within 6 months before screening.
- •C. Major surgery within 4 weeks before screening.
- •4) Pregnant or lactating individuals.
- •5) Fertile women or men unwilling to use effective contraception during the clinical trial period:
- •A. Fertile women are defined as those who have experienced menstruation and do not meet any of the following criteria:
- •i. Postmenopausal status (defined as no menses for at least 12 months without any other pathologic or physiologic cause and confirmed by follicle-stimulating hormone (FSH) levels = 40 IU/L at screening).
- •ii. Undergone hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion.
- •iii. Clinically confirmed congenital or acquired ovarian insufficiency preventing pregnancy.
- •B. Men with azoospermia (defined as having undergone vasectomy for at least 1 year or due to underlying medical conditions) are considered infertile.
- •C. Effective contraception is defined as follows†:
- •i. Single method (any one of the following is acceptable):
- •- Intrauterine device (IUD).
- •- Vasectomized male partner of female trial subjects.
- •- Contraceptive implant.
- •ii. Dual methods (any two of the following are required):
- •- Barrier methods containing spermicide (cannot be used with cervical cap/spermicide).
- •- Cervical cap with spermicide (applicable to nulliparous women only).
- •- Contraceptive sponge (applicable to nulliparous women only).
- •- Male condoms or female condoms (cannot be used together).
- •- Hormonal contraceptives: Oral contraceptive pills (combination estrogen/progestin pills or progestin-only pills), transdermal contraceptive patch, vaginal contraceptive ring, or subcutaneous contraceptive injection.
- •If local regulations/guidelines restrict the listed contraceptive methods, they are not considered acceptable contraception for trial subjects at the participating trial sites in that country/region.
- •iii. All other female trial subjects (including those with tubal ligation) are considered at risk of pregnancy. All male trial subjects engaging in sexual activity must agree to consistently and correctly use condoms throughout the entire period of the trial drug administration (or starting 14 days before the first administration in the case o
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