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: 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
RECRUITING
Beijing
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING
Hangzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Italy
A O U Sant Orsola Malpighi
RECRUITING
Bologna
Japan
National Cancer Center Hospital
COMPLETED
Chūōku
National Cancer Center Hospital East
RECRUITING
Kashiwa
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Poland
Pratia Onkologia Katowice
RECRUITING
Katowice
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
RECRUITING
Kielce
Aidport Sp z o o
RECRUITING
Skorzewo
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara University Medical Faculty
RECRUITING
Ankara
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Ankara
Koc University Medical Faculty
RECRUITING
Istanbul
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-05-28
Estimated Completion Date:2028-10-18
Participants
Target number of participants:160
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.