EUCTR2017-000106-38-ES进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
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, 1 or 2.
- •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/1.73m2) 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.
- •Note: Subjects with secondary DLBCL CNS involvement are eligible (not applicable for Cohort 5).
- •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 subsequent therapies are given after last relapse with SD/PD as best response, the tissue from that last relapse will be considered adequate to participate in the trial.
- •8. For subjects with NHL and Richter’s transformed CLL: Subject must have positron emission tomography (PET)-positive disease as per Lugano Classification (Cheson, 2014).
- •9. For subjects with PCNSL: Subjects must have disease that is objectively measurable by International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary Central Nervous System (CNS) Lymphoma (Abrey, 2
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. History of another primary malignancy that has not been in remission for at least 2 years prior to enrollment. The following are exempt from the 2-year limit if curatively treated:
- •Non-melanoma skin cancer
- •Localized prostate cancer
- •Cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear
- •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, paresis, aphasia, stroke, 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 equivalent) within 7 days prior to leukapheresis or
- •72 hours prior to JCAR017 infusion. Physiologic replacement, topical, and inhaled steroids are permitted.
- •Low-dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide = 300 mg/m2) given after leukapheresis to maintain disease control must be stopped = 7 days prior to LD chemotherapy.
- •Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week prior to leukapheresis. Oral anticancer agents, including lenalidomide and ibrutinib,are allowed if at least 3 half-lives have elapsed prior to leukapheresis.
- •Lymphotoxic chemotherapeutic agents (eg, cyclophosphamid
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