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临床试验/NL-OMON52985
NL-OMON52985已完成2 期

A PHASE 2, SINGLE-ARM, MULTI-COHORT, MULTI-CENTER TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA - JCAR017-BCM-001 (0451/0216)

Celgene Corporation0 个研究点目标入组 6 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
6
研究概览入排标准研究者记录与标识符相似试验

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
18 至 64（—）

入选标准

  • •Subjects must satisfy the following criteria to be enrolled in the study:
  • •1. Subject is >= 18 years of age at the time of signing the informed consent
  • •2. Subject must understand and voluntarily sign an ICF prior to any
  • •study-related assessments/procedures being conducted
  • •3. Subject is willing and able to adhere to the study visit schedule and other
  • •protocol requirements
  • •4. Investigator considers the subject is appropriate for adoptive T cell therapy
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • •Subjects not eligible for transplant (TNE) in Cohorts 2 and 3 and subjects in
  • •Cohort 5 may be enrolled with ECOG of 2 only if they meet all other
  • •inclusion/exclusion criteria.
  • •6. Subjects with one of the following:
  • •Cohort 1: Subjects with DLBCL NOS (de novo or tFL), HGBL and FL3B per WHO
  • •2016 classification (Swerdlow, 2016), after >= 2 lines of therapy*, including an
  • •anthracycline and rituximab (or other CD20-targeted agent)
  • •Cohort 2: Transplant not eligible subjects with DLBCL NOS (de novo or tFL),
  • •HGBL and FL3B per WHO 2016 classification (Swerdlow, 2016), who failed first
  • •line therapy*, including an anthracycline and rituximab (or other CD20-targeted
  • •o Transplant not eligible subjects will include those who are deemed ineligible
  • •for high-dose chemotherapy and HSCT due to age, performance status or
  • •comorbidity, while also having adequate organ function for CAR T cell
  • •treatment. At the very least, subjects have to meet one of the following
  • •a) Age >= 70 years
  • •b) ECOG performance status >= 2
  • •c) Impaired pulmonary function (DLCO <= 60%, adjusted for hemoglobin
  • •concentration using the Dinakara equation)
  • •d) Impaired cardiac function (LVEF < 50%)
  • •e) Impaired renal function (CrCl < 60 mL/min)
  • •f) Impaired hepatic function (AST/ALT > 2 x ULN, bilirubin >= 2 mg/dL or
  • •cirrhosis Child-Pugh B or C)
  • •o Subjects must fulfill all other inclusion and exclusion criteria
  • •Cohort 3 (Japan only): Subjects meeting eligibility criteria for either
  • •Cohort 1 or 2
  • •Cohort 4: Subjects with newly diagnosed HGBL. Subjects must be eligible for
  • •anthracycline and rituximab (or other CD20-targeted agent) containing regimen
  • •as induction prior to consolidation with JCAR017**
  • •Cohort 5: Subjects with PCNSL who failed first line therapy with HDCT and
  • •ASCT, or who failed to proceed to HDCT and ASCT due to failure of PBSC
  • •mobilization or insufficient response at the completion of induction therapy
  • •with high-dose methotrexate-based polychemotherapy regimen (eg, high dose
  • •methotrexate, high dose cytarabine, rituximab and thiotepa [MATRix regimen])
  • •Cohort 6: (REMOVED)
  • •Cohort 7: Subjects meeting eligibility criteria for Cohort 1 and suitable for
  • •outpatient treatment***
  • •* For subjects with transformed disease, the subject should have had at least 2
  • •lines of systemic therapy for his/her transformed disease (ie, DLBCL) for
  • •Cohort 1 and 1 line for Cohort 2 to be eligible. Lines of therapy do not
  • •include those given for a previously indolent condition (ie, follicular
  • •lymphoma). Subjects do NOT have to have anthracycline for their DLBCL if
  • •received for indolent disease.
  • 另有 2 项未显示

排除标准

  • •The presence of any of the following will exclude a subject from enrollment:
  • •1. Subject has any significant medical condition, laboratory abnormality, or
  • •psychiatric illness that would prevent the subject from participating in the
  • •2. Subject has any condition including the presence of laboratory
  • •abnormalities, which would place the subject at unacceptable risk if
  • •participating in the study
  • •3. Subject has any condition that confounds the ability to interpret data from
  • •4. Subjects with T cell rich/histiocyte rich large B-cell lymphoma (THRBCL),
  • •primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma
  • •(PMBCL), Epstein-Barr virus (EBV) positive DLBCL of the elderly, Burkitt
  • •lymphoma, and intraocular lymphoma
  • •5. Subjects with prior history of malignancies, other than aggressive r/r NHL,
  • •unless the subject has been in remission for >= 2 years with the exception of
  • •the following noninvasive malignancies:
  • •Basal cell carcinoma of the skin
  • •Squamous cell carcinoma of the skin
  • •Carcinoma in situ of the cervix
  • •Carcinoma in situ of the breast
  • •Incidental histologic finding of prostate cancer (T1a or T1b using the TNM
  • •[tumor, nodes, metastasis] clinical staging system) or prostate cancer that is
  • •Other completely resected stage 1 solid tumor with low risk for recurrence
  • •6. Treatment with any prior gene therapy product
  • •7. Subjects who have received previous CD19-targeted therapy
  • •8. Human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C:
  • •Subjects with a history of or active HIV are excluded
  • •Subjects with active hepatitis B, or active hepatitis C are excluded
  • •Subjects with a negative polymerase chain reaction (PCR) assay for viral load
  • •for hepatitis B or C are permitted. Subjects positive for hepatitis B surface
  • •antigen and/or anti-hepatitis B core antibody with negative viral load are
  • •eligible and should be considered for prophylactic antiviral therapy
  • •9. Subjects with uncontrolled systemic fungal, bacterial, viral or other
  • •infection (including tuberculosis) despite appropriate antibiotics or other
  • •treatment at the time of leukapheresis or JCAR017 infusion
  • •10. Presence of acute or chronic graft-versus-host disease (GVHD)
  • •11. Active autoimmune disease requiring immunosuppressive therapy
  • •12. History of any one of the following cardiovascular conditions within the
  • •past 6 months:
  • •Heart failure class III or IV as defined by the New York Heart Association
  • •Cardiac angioplasty or stenting
  • •Myocardial infarction
  • •Unstable angina
  • •Other clinically significant cardiac disease
  • •13. History or presence of clinically relevant CNS pathology not related to
  • •disease under study such as epilepsy, seizure, aphasia, stroke, cerebral edema,
  • •severe brain injuries, dementia, Parkinson's disease, cerebellar disease,
  • •organic brain syndrome, or psychosis 14. Pregnant or nursing women
  • •15. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment
  • •with fludarabine or cladribine within 3 months of leukapheresis
  • •16. Use of the following (see Section 8.2 for full details):
  • •Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or
  • 另有 2 项未显示

研究者

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