A Phase Ib/II, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma
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Study Summary
To evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) per ASTCT 2019 criteria. Tumor response per investigator (Lugano criteria).
To report biomarker analyses from pts with R/R LBCL and the relationship between these biomarkers and clinical outcomes.
Biomarker analyses conducted in this study include peripheral blood and tumor-based assessments. Peripheral blood assessments included CAR T-cell expansion (quantitative polymerase chain reaction-based transgene and flow cytometry assays); B-cell depletion and recovery (TBNK [BD Biosciences, CA], and custom B-cell flow cytometry panels); and cytokine analysis (V-plex proinflammatory panel [Meso Scale Discovery, MD]). Tumor-based assessments included CD20 and CD19 target expression analysis by immunohistochemistry (IHC). Gene expression analysis using RNA sequencing assessed LymphoMAP tumor microenvironment (TME) archetypes and their association with tx response.
- Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consentTumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positiveMust meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocolMeasurable disease as defined by Lugano 2014 classificationEastern cooperative oncology group (ECOG) performance status of 0 to 2
- History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)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 apheresisHistory of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorderKnown history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous systemCurrent active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infectionDiagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's MacroglobulinemiaAny prior solid organ or allogeneic stem cell transplantationAutologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis
Clinical Study Information for Healthcare Providers
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