A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

88998377LYM1001

The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation) and to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).

2024-05-28

2027-10-29

2027-10-29

Recruiting

Early phase I

160

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2024-06-24