NCT05993949进行中（未招募）1 期
Phase 1b Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Feasibility of dasatinib pulses
研究概览
简要总结
To assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory B-precursor ALL defined as one of the following:
- •Primary refractory disease (>=5% blasts or persistent extramedullary disease following induction therapy)
- •First or later relapse of marrow or extramedullary disease
- •Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or next-generation sequencing
- •Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from transplant at time of enrollment
- •Patients with isolated, asymptomatic CNS relapse will be eligible
- •Age >=18 years
- •Eastern cooperative oncology group (ECOG) performance status of 0-2
- •Adequate renal, hepatic, pulmonary and cardiac function defined as:
- •Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min
- •Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome.
- •Cardiac ejection fraction ≥ 50%, no evidence of clinically significant pericardial effusion, and no clinically significant arrhythmias
- •Baseline oxygen saturation > 92% on room air
- •QTc ≤ 500ms
- •In individuals previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood by flow cytometry or extramedullary site by IHC or flow cytometry
- •Negative serum or urine beta-HCG test in females of childbearing potential within 3 weeks of enrollment
- •Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study Page 10 of 83 Version 1.0 dated 27-April-2023 and for six (6) months after receiving the preparative conditioning regimen.
- •Must be able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent.
排除标准
- •History of dasatinib intolerance
- •Known sensitivity or allergy to aminoglycosides or any agents/reagents used in this study
- •Blast count > 75% in the bone marrow.
- •History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years
- •Presence of CNS-3 disease with neurological changes
- •History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage with clinical signs or symptoms
- •History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond or any known bone marrow failure syndrome
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- •Primary immunodeficiency
- •Known infection with HIV, hepatitis B (HBsAg positive) or untreated hepatitis C virus
- •Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- •Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
- •Pregnant or breast feeding
- •Patients with known autoimmune disease requiring the use of systemic immunosuppressive therapy within the last year
- •Corticosteroid therapy within 7 days prior to enrollment
- •Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
- •Live vaccine ≤ 4 weeks prior to enrollment
- •Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment
研究组 & 干预措施
Dasatinib
Experimental
Oral dasatinib 100mg
干预措施: Dasatinib (Drug)
结局指标
主要结局
Feasibility of dasatinib pulses
时间窗: 1 month
Feasibility of administering oral dasatinib pulses (3 consecutive doses per week) during the first month following Tecartus infusion. Feasibility will be defined as the ability of 8 out of 20 subjects to miss no more than one cycle (defined as one week of at least three consecutive days of dasatinib) within the first month following Tecartus infusion.
次要结局
- Overall response rate(3 months)
- MRD-negative Complete Response (CR)(3 months)
- Duration of CR in responders(2 years)
- Progression Free Survival (PFS) following Tecartus plus dasatinib(2 years)
- Overall Survival (OS) following Tecartus plus dasatinib(2 years)
- Safety of oral dasatinib pulses(2 years)
- Complete Response (CR)(3 months)
研究者
研究点 (1)
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