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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Refractory B-Cell NHL; Relapsed B-cell NHL; Lymphoma, Non-Hodgkin

Treatments: Drug: JNJ-88998377

Study type: Interventional

Funder types: Industry

Identifiers

NCT06470438

2023-509258-71-00 (Registry Identifier)

88998377LYM1001

Details and patient eligibility

About

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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Part A: Dose Escalation

Experimental group

Description:

Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D).

Treatment:

Drug: JNJ-88998377

Part B: Dose Expansion

Experimental group

Description:

Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data.

Treatment:

Drug: JNJ-88998377