CTIS2023-508508-39-01进行中（未招募）1 期
A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell lymphoma - M-2018-344
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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 65+（—）
- 性别
- All
入选标准
- •1. Histologically confirmed DLBCL or associated subtype, defined by WHO 2016 classification: o DLBCL not otherwise specified (NOS) o High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements o High-grade B cell lymphoma, NOS o Primary mediastinal (thymic) large B cell lymphoma o Transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma, follicular lymphoma Grade 3) 1.1. CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL) 2. Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT (only 2.4 applicable to CNS cohort) 2.1. Chemotherapy-refractory disease is defined as one or more of the following: • Persistent disease after last line of therapy: o Progressive disease (PD) as best response to most recent therapy regimen o Stable disease (SD) as best response to most recent therapy o Partial response (PR) with measurable lesion(s) and Deauville score of at least 4, that in the opinion of the investigator requires change of treatment to CAR-T for improvement in treatment outcome OR • Relapsed or persistent disease after prior ASCT for lymphoma o If salvage therapy is given post-ASCT, the individual must have had persistent disease (as described above) or relapsed after the last line of therapy 2.2. Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen 2.3. Not intended for ASCT is defined as meeting one of the following criteria: • Chemotherapy-refractory disease after salvage therapy • Disease progression or relapse = 12 months after salvage therapy • Intolerance to salvage therapy • Age = 70 2.4. CNS Cohort: Subjects with relapsed/refractory PCNSL that have failed (or unable to tolerate) first-line therapy: • First-line therapy is defined as either high dose methotrexate-based therapy, temozolomide, high dose cytarabine, pemetrexed, lenalidomide or bruton thyrosine kinase (BTK) inhibitor-based therapy. • Unable to tolerate therapy is defined as Grade 3+ acute kidney injury (AKI) and/or transaminitis preventing repeat treatment exposure • Persistent disease after last line of therapy (as in 2.1) • No contraindications for MRI evaluation 2.5. CNS Cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least 1 prior line of systemic therapy • Prior lines of systemic therapy should include an anti- CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and/or an autologous stem cell transplant • No contraindications for MRI evaluation In addition, all subjects must have: 3. Age =18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to DLBCL 5. Measurable disease according to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma (Cheson et al, 2014) for DLBCL and SCNSL while IPCG criteria for the primary PCNSL., Continued translation (1-5), 6. CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy; however, 6.1 Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion.
排除标准
- •1. Primary CNS lymphoma (not applicable to CNS cohort) 2. Richter’s transformed DLBCL arising from chronic lymphocytic leukemia (CLL) 3. Unable to give informed consent 4. Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive 5. Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and/or nucleic acid testing 6. Known history of active seizure or presence of seizure activities except CNS lymphoma related, pharmacologically controlled seizure 7. Known history of CVA within prior 12 months 8. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease 9. Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity 9.1. For CNS Cohort: • Bulky leptomeningeal disease and or CSF protein >100 mg/Dl • Recent (within 2 months) whole brain radiotherapy (WBRT) 10. Active systemic fungal, viral or bacterial infection 11. Pregnant or breast-feeding woman 12. Previous or concurrent malignancy with the following exceptions: • Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry) • In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study • Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of = 2 years • A primary malignancy which has been completely resected / treated with curative intent and in complete remission of = 2 years 13. History of non-neurologic autoimmune disease (e.g. Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive or systemic disease modifying agents within the last 2 years 14. Medical condition requiring prolonged use of systemic corticosteroids equivalent to Prednisone >10 mg/day 15. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment 16. Concurrent radiotherapy (normal tissue sparing palliative radiotherapy allowed up to time of lymphodepletion). For systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis 17. Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline. (Appendix 6, Section 13.6) 18. History of severe immediate hypersensitivity reaction to any of the agents used in this study 19. Refusal to participate in additional lentiviral gene therapy long-term follow-up (LTFU) protocol 20. Prior CAR-T therapy for any indication or systemic gene-modifying therapy for DLBCL 21. Prior allogeneic stem cell transplant for any indication. 22. Prior Bispecific T cell engaging (BITE) antibodies for cancer therapy 23. Prior T cell receptor-engineered T cell therapy
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