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

NCT ID: NCT06470438

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2028-10-18

Brief Summary

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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), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin Refractory B-Cell NHL Relapsed B-cell NHL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Dose Escalation

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).

Group Type EXPERIMENTAL

JNJ-88998377

Intervention Type DRUG

JNJ-88998377 will be administered.

Part B: Dose Expansion

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.

Group Type EXPERIMENTAL

JNJ-88998377

Intervention Type DRUG

JNJ-88998377 will be administered.

Interventions

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JNJ-88998377

JNJ-88998377 will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.
* For Part A and B: 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Beijing Cancer Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status RECRUITING

A O U Sant Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

National Cancer Center Hospital

Chūōku, , Japan

Site Status COMPLETED

National Cancer Center Hospital East

Kashiwa, , Japan

Site Status RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status RECRUITING

Pratia Onkologia Katowice

Katowice, , Poland

Site Status RECRUITING

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku

Kielce, , Poland

Site Status RECRUITING

Aidport Sp z o o

Skorzewo, , Poland

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Koc University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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China Italy Japan Poland South Korea Taiwan Turkey (Türkiye)

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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88998377LYM1001

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509258-71-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

88998377LYM1001

Identifier Type: -

Identifier Source: org_study_id