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 - n.a.

CELGENE CORPORATIO0 个研究点目标入组 124 人开始时间: 2021年1月21日最近更新: 2024年1月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 124

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Subject is = 18 years of age at the time of signing the informed consent form (ICF).
•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 (Cohort 1, 4, 5 or 6). Subjects not eligible for transplant (TNE) with ECOG performance status 0, 1 or 2 may be enrolled in Cohort 2 or 3 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), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) 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), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B per WHO 2016 classification (Swerdlow, 2016), who failed first line therapy including an anthracycline and rituximab (or other CD-20-targeted agent).
•- Transplant not eligible subjects will include those who are deemed ineligible for high-dose chemotherapy and HSCT due to age, performance status or comorbidity. At the very least, subjects have to meet one of the following criteria:
•age = 70 years, ECOG performance status = 2, impaired pulmonary function (DLCO = 60%), impaired cardiac function (LVEF < 50%), impaired renal function (CrCl < 60 mL/min) or impaired hepatic function (AST/ALT > 2x ULN, bilirubin > 2 mg/dL or cirrhosis Child-Pugh B or C).
•- Subjects must fulfil all other in- and exclusion criteria
•Cohort 3: (Japan only): Subjects meeting eligibility criteria for either Cohort 1 or 2.
•Cohort 4: Subjects with high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) who failed first line therapy*. Subjects may be screened at time of initial diagnosis and leukapheresis may be performed prior to initiation of first line therapy.
•Cohort 5: Subjects with PCNSL after = 1 line of therapy, including high-dose methotrexate.
•Cohort 6: Subjects with Richter's transformation after = 1 line of therapy for Richter's transformation.
•*For subjects with transformed disease, the subject should have had at least 2 lines of systemic therapy for his/her transformed disease (i.e. 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 (i.e. follicular lymphoma). Subjects do NOT have to have anthracycline for their DLBCL if received for indolent disease.
•Note: Subjects with secondary CNS lymphoma involvement may enroll in Cohorts 1 to 4 and 6; subjects with PCNSL are eligible for Cohort 5.
•Subject selection must consider clinical risk factors for severe adverse events (AEs) and alternative treatment options. Subjects should only be enrolled if the Investigator considers the potential benefit outweighs the risk for the subject.
•7. Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
•Note: If the subject did n

排除标准

•1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•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 the study.
•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), EBV positive DLBCL of the elderly and Burkitt 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 non-invasive 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 curative
•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. Previous history of or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
•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 (NYHA)
•Cardiac angioplasty or stenting
•Myocardial infarction
•Unstable angina
•Other clinically significant cardiac disease
•13. History or presence of clinically relevant CNS pathology 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
•Please refer to protocol section 4.3 for inclusion criteria 16-18

研究者

发起方

CELGENE CORPORATIO

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