A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-88998377 for patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma, which means their cancer has come back or hasn’t responded to previous treatments. The trial is divided into two parts: the first part will test different doses of the medication to find the safest amount to use, and the second part will continue to assess its safety at that recommended dose.

To be eligible for this trial, participants need to have a confirmed diagnosis of B-cell Non-Hodgkin's Lymphoma and be in a situation where their disease has either returned after treatment or hasn’t improved with other therapies. They should also be generally healthy enough to participate and expect to live at least 12 weeks. Participants will need to follow specific guidelines during the study period. If someone has had recent major surgery or has certain other health issues, they may not be able to join the trial. Overall, this study aims to provide more information about the safety of JNJ-88998377 and how well it works for patients in this situation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
• • Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
• • Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Participants have a life expectancy of greater than or equal to (\>=) 12 weeks
• • Be willing and able to adhere to the lifestyle restrictions specified in the protocol
• Exclusion Criteria:
• • Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
• • History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment as malignancies can interfere with study endpoints
• • Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
• • Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
• • Participant received an autologous stem cell transplant less than or equal to (\<=) 3 months before the first dose of study treatment