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Clinical Trials in China / NCT06470438
Active, not recruiting Phase 1

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

NCT06470438 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2024-05-28
Last updated
2026-08-28

Condition(s) studied

Lymphoma, Non-HodgkinRefractory B-Cell NHLRelapsed B-cell NHL

Investigational drug(s) / intervention(s)

JNJ-88998377

JNJ-88998377: JNJ-88998377 will be administered.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China
Sun Yat Sen University Cancer Center Guangzhou China
The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou China
Fudan University Shanghai Cancer Center Shanghai China
Tianjin Medical University Cancer Institute and Hospital Tianjin China
A O U Sant Orsola Malpighi Bologna Italy
National Cancer Center Hospital Chūōku Japan
National Cancer Center Hospital East Kashiwa Japan
The Cancer Institute Hospital of JFCR Tokyo Japan
Pratia Onkologia Katowice Katowice Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku Kielce Poland
Aidport Sp z o o Skorzewo Poland
Seoul National University Hospital Seoul South Korea
Samsung Medical Center Seoul South Korea
National Taiwan University Hospital Taipei Taiwan
Linkou Chang Gung Memorial Hospital Taoyuan Taiwan
SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi Ankara Turkey (Türkiye)
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi Ankara Turkey (Türkiye)
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06470438 on ClinicalTrials.gov ↗ ← All trials in China