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)
Parts A and B: Number of Participants with Adverse Events (AEs) — Upto 3 years 4 months An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product.
Part A: Number of Participants with Dose Limiting Toxicity (DLTs) — Cycle 1 (21 days) Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity.
Trial sites (19)
Facility
City
Region
Status
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)
More Janssen Research & Development, LLC trials in China
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.
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