A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
Lymphoma, B-Cell | Lymphoma, Non-HodgkinThis is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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)
Lieu de l'étude
Princess Margaret Cancer Centre University Health Network
Princess Margaret Cancer Centre University Health NetworkToronto, Ontario
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Janssen Research & Development, LLC
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05421663