A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT06470438
Last Updated: 2025-12-24
Study Results
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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RECRUITING
PHASE1
170 participants
INTERVENTIONAL
2024-05-28
2028-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
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).
JNJ-88998377
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.
JNJ-88998377
JNJ-88998377 will be administered.
Interventions
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JNJ-88998377
JNJ-88998377 will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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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
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 District, , Taiwan
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Koc University Medical Faculty
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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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