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A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Status: Active_not_recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Cancer Hospital
Beijing
Sun Yat Sen University Cancer Center
Guangzhou
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou
Fudan University Shanghai Cancer Center
Shanghai
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Italy
A O U Sant Orsola Malpighi
Bologna
Japan
National Cancer Center Hospital
Chūōku
National Cancer Center Hospital East
Kashiwa
The Cancer Institute Hospital of JFCR
Tokyo
Poland
Pratia Onkologia Katowice
Katowice
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
Kielce
Aidport Sp z o o
Skorzewo
Republic of Korea
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Taiwan
National Taiwan University Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan District
Turkey
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
Ankara
SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
Ankara
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
Istanbul
Time Frame
Start Date:2024-05-28
Completion Date:2028-12-29
Participants
Target number of participants:58
Treatments
Experimental: 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).
Experimental: 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.