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

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma, Non-Hodgkin; Relapsed B-cell NHL; Refractory B-Cell NHL
• Intervention / Treatment: Drug: JNJ-88998377

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Guangzhou, China, 510062
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310002
    • The First Affiliated Hospital Zhejiang University College of Medicine
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300181
    • Tianjin Medical University Cancer Institute and Hospital
• Italy
  • Bologna, Italy, 40138
    • A O U Sant Orsola Malpighi
• Japan
  • Chūōku, Japan, 104 0045
    • National Cancer Center Hospital
  • Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
• Poland
  • Katowice, Poland, 40 519
    • Pratia Onkologia Katowice
  • Kielce, Poland, 25-734
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
  • Skorzewo, Poland, 60-185
    • Aidport Sp z o o
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• Taiwan
  • Taipei, Taiwan, 10043
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33382
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06200
    • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
  • Ankara, Turkey (Türkiye), 06620
    • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
  • Istanbul, Turkey (Türkiye), 34010
    • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: JNJ-88998377; JNJ-88998377 will be administered.
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.	Drug: JNJ-88998377; JNJ-88998377 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts A and B: Number of Participants with Adverse Events (AEs)	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.	Upto 3 years 4 months
Part A: Number of Participants with Dose Limiting Toxicity (DLTs)	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.	Cycle 1 (21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of JNJ-88998377	Plasma concentration of oral dose of JNJ-88998377 will be assessed.	Up to first 12 weeks
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377	Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.	Up to first 12 weeks
Maximum Plasma Concentration (Cmax) of JNJ-88998377	Cmax of JNJ-88998377 will be reported.	Up to first 12 weeks
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377	Cmin of JNJ-88998377 will be reported.	Up to first 12 weeks
Percentage of Participants With Overall Response (OR)	OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria.	Up to 3 years 4 months
Time to Response (TTR)	TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria.	From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
Duration of Response (DOR)	DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death.	From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): December 29, 2028

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 88998377LYM1001 (Other Identifier: Janssen Research & Development, LLC); 2023-509258-71-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes