A phase Ib multicenter, open-label, study of JNJ-90014496, an autologous CD19/CD20 Bi-specific CAR-T cell therapy in adult participants with relapsed or refractory B-cell non-Hodgkin lymphoma

Janssen-Cilag International NV0 个研究点目标入组 92 人开始时间: 2024年4月18日最近更新: 2024年5月13日

适应症

试验速览

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•1. Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
•2. All participants must have relapsed or refractory disease for each histologic subtype - Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent-Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
•3. Tumor must be cluster of differentiation (CD) 20 positive
•4. Measurable disease as defined by Lugano 2014 classification
•5. Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

•1. Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
•2. Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
•3. Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
•4. Uncontrolled active infections
•5. History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
•6. History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association [NYHA] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
•7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder
•8. Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
•9. Active central nervous system (CNS) involvement by malignancy
•10. Current active liver or biliary disease (except for Gilbert’s syndrome or asymptomatic gallstones)

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