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

Last updated: May 7, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Treatment

JNJ-88998377

Clinical Study ID

NCT06470438
88998377LYM1001
88998377LYM1001
2023-509258-71-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants have histologically or cytologically confirmed B-cell non-Hodgkin'sLymphoma (NHL) according to the 2022 World Health Organization (WHO) classificationwith relapsed or refractory disease

  • Participants have measurable disease or meet all requirements for adequate responseassessment 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 theprotocol

Exclusion

Exclusion Criteria:

  • Participant with active or prior history of B-cell NHL involving the central nervoussystem (CNS) and leptomeningeal involvement

  • History of malignancy (other than the disease under study in the cohort to which theparticipant is assigned) within 1 year prior to the first administration of studytreatment.

  • For Part A and B: Participant having known allergies, hypersensitivity, orintolerance to the excipients of JNJ-88998377

  • Participant had major surgery or had significant traumatic injury within 30 daysbefore first dose of study treatment or has not recovered from surgery and must nothave major surgery planned during the time the participant is receiving studytreatment

  • Participant received an autologous stem cell transplant less than or equal to (<=) 3months before the first dose of study treatment

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: JNJ-88998377
Phase: 1
Study Start date:
May 28, 2024
Estimated Completion Date:
December 29, 2028

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, 100142
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510062
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510062
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou 1809858, 510062
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hang Zhou Shi, 310002
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310002
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou 1808926, 310002
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, 200032
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300181
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947, 300181
    China

    Site Not Available

  • A O U Sant Orsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • A O U Sant Orsola Malpighi

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, 104 0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chūōku, 104 0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chūōku 10262791, 104 0045
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa 1859924, 277-8577
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Tokyo 1850147, 135 8550
    Japan

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Pratia Hematologia Sp z o o

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40 519
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice 3096472, 40 519
    Poland

    Site Not Available

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25-734
    Poland

    Active - Recruiting

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku

    Kielce, 25-734
    Poland

    Site Not Available

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku

    Kielce 769250, 25-734
    Poland

    Site Not Available

  • Aidport Sp z o o

    Skorzewo, 60-185
    Poland

    Site Not Available

  • Aidport Sp z o o

    Skorzewo 3085749, 60-185
    Poland

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10043
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10043
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33382
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District, 33382
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 33382
    Taiwan

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 06590
    Turkey

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Site Not Available

  • Koc University Medical Faculty

    Istanbul, 34010
    Turkey

    Site Not Available

  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

    Ankara, 06620
    Turkey (Türkiye)

    Site Not Available

  • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi

    Ankara, 06200
    Turkey (Türkiye)

    Site Not Available

  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

    Ankara 323786, 06620
    Turkey (Türkiye)

    Site Not Available

  • Ankara University Medical Faculty

    Ankara 323786, 06590
    Turkey (Türkiye)

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara 323786, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi

    Ankara 323786, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

    Istanbul, 34010
    Turkey (Türkiye)

    Site Not Available

  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

    Istanbul 745044, 34010
    Turkey (Türkiye)

    Site Not Available

  • Koc University Medical Faculty

    Istanbul 745044, 34010
    Turkey (Türkiye)

    Active - Recruiting

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