A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called JNJ-90014496 for adults with a type of blood cancer known as relapsed or refractory B-Cell Non-Hodgkin Lymphoma. This therapy uses modified immune cells, known as CAR T-cells, to target specific proteins on the cancer cells. The trial is currently recruiting participants who are at least 18 years old and have been diagnosed with certain aggressive forms of this cancer. Eligible candidates must have already received multiple treatments that did not work, and their cancer must be confirmed to express specific markers (CD19 and/or CD20) that the therapy targets.

Participants in this study will receive the JNJ-90014496 treatment and will be monitored for how well it works and any side effects. It's important to note that there are specific health criteria for joining the trial; for example, individuals with certain heart conditions or recent severe infections may not be eligible. This trial aims to provide more options for patients whose previous treatments have not been successful, potentially improving their chances of recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent
• • Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
• • Must meet the following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have had \>= 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); Relapsed or refractory follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
• • Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL
• • Measurable disease as defined by Lugano 2014 classification
• • Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort
• Exclusion Criteria:
• • Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma
• • Any prior solid organ or allogeneic stem cell transplantation
• • Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
• • Uncontrolled active infections
• • History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis \[DVT\])
• • 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
• • History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
• • Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
• • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)