EUCTR2021-003815-25-ES进行中（未招募）1 期
A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). - Euplagia-1
CellPoint B.V.0 个研究点目标入组 45 人开始时间: 2021年7月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent form
- •2.Age = 18 years
- •3.Histologically confirmed diagnosis of CD19+ CLL or SLL with an indication for therapy according to iwCLL criteria, Richter’s transformation is allowed
- •4.Documented relapsed or refractory disease after at least 2 prior lines of therapy:
- •Subjects must have been exposed to Bruton tyrosine kinase (BTK)-inhibitors (e.g. ibrutinib, acalabrutinib)
- •Richter’s patients who failed a BTK-inhibitor are eligible regardless of number of prior lines of therapy received
- •5.Measurable disease according to iwCLL
- •6.ECOG performance status of 0 or 1
- •7.Adequate bone marrow function defined as:
- •Absolute neutrophil count (ANC) = 500/µL or = 0.5 × 109/L (without G-CSF support within 7 days of the laboratory test or pegylated G-CSF support within 14 days of the laboratory test)
- •Platelet count = 50.000/µL or = 50 x 109/L (without prior platelet transfusion within 7 days before the laboratory test)
- •Absolute lymphocyte count = 300/µL or = 0.3 × 109/L;
- •CD3+ count = 150/µL or = 0.15 × 109/L
- •8.Adequate renal, hepatic and pulmonary function defined as:
- •Serum albumin = 3.4 g/dL
- •Creatinine clearance (Cockcroft Gault) = 30 mL/min
- •Aspartate aminotransferase (AST) = 3 × upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) = 3 × ULN
- •Total bilirubin = 2 x ULN, except in subjects with Gilbert’s syndrome
- •No clinically significant pleural effusion
- •Baseline oxygen saturation > 92% on room air
- •9.Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of cyclophosphamide and fludarabine
- •10.Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception (failure rate of < 1% per year when used consistently and correctly) and agree to remain on a highly effective method of contraception from the time of signing the informed consent form until at least 6 months after BCN-CP01 infusion. Subjects must agree to not donate eggs or sperm during this period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Prior treatment:
- •Any anti-CD19 targeted therapy
- •Salvage systemic therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to leukapheresis
- •Allogeneic stem cell transplant within 6 months before leukapheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Subjects with active significant (overall Grade = II, Seattle criteria) active graft-versus-host disease (GVHD) or moderate/ severe chronic GVHD (NIH consensus criteria) requiring systemic steroids are excluded.
- •Corticosteroid therapy at a pharmacologic dose (> 10 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs are not allowed for 7 days prior to leukapheresis and > 72 hours prior to BCN-CP01 infusion (if restarted)
- •2.History of malignancy other than lymphoma, except:
- •a.non-melanoma skin cancer
- •b.Carcinoma in situ (e.g. skin, cervix, bladder, breast) and disease free for at least 3 years prior to screening
- •c.Superficial bladder cancer
- •d.Asymptomatic low-grade or curatively treated localized prostate cancer for which watch-and-wait approach is standard of care
- •e.Any other cancer that has been in remission for =3 years prior to enrollment
- •3.History of BTK-associated side effects (e.g. symptomatic atrial fibrillation) or co-morbidities (e.g. oral anticoagulation use , severe hemophilia, or von Willebrand’s disease, etc.) that would prevent the patient from taking ibrutinib during the screening phase
- •4.Contraindication for Fludarabine or Cyclophosphamide
- •5.Known allergy or hypersensitivity to tocilizumab
- •6.Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less
- •7.Active CNS involvement (with neurological changes) by disease under study, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was > 4 weeks before screening
- •8.Clinically significant cardiac disease within 12 months of screening such as:
- •Impaired cardiac function (LVEF < 45%) as assessed by echocardiogram performed = 4 weeks prior to screening
- •Evidence of pericardial effusion as determined by echocardiogram
- •New York Heart Association Class III or IV congestive heart failure
- •Clinically significant arrhythmias
- •9.Primary immunodeficiency
- •10.Stroke or seizure within 6 months of screening
- •11.History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within 2 years prior to screening
- •12.Infection with HIV, hepatitis B or hepatitis C virus. A history of hepatitis B or C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
- •13.Uncontrolled infection or infection requiring antimicrobials for management, at screening
- •14.Vaccinated with live attenuated vaccine = 4 weeks prior to leukapheresis
- •15.Pregnant or nursing women, or planning to become pregnant within 6 months after BCN-CP01 infusion
- •16.No major surgery =2 weeks prior to leukapheresis
- •17.In the investigator’s judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
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