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

NCT06470438 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 88998377LYM10012023-509258-71-00
• Study Type: interventional
• Target: 58
• Locations: 7 countries
• Sites: 19

Brief 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).

Conditions

Refractory B-Cell NHL; Relapsed B-cell NHL; Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Plasma Concentration of JNJ-88998377

  Up to first 12 weeks

• Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377

  Up to first 12 weeks

• Maximum Plasma Concentration (Cmax) of JNJ-88998377

  Up to first 12 weeks

• Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377

  Up to first 12 weeks

• Percentage of Participants With Overall Response (OR)

  Up to 3 years 4 months

Study Arms (2)

Part A: Dose Escalation

EXPERIMENTAL

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

Part B: Dose Expansion

EXPERIMENTAL

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

Interventions

JNJ-88998377 DRUG

JNJ-88998377 will be administered.

Part A: Dose Escalation; Part B: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (19)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, 510062, China

Location

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310002, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300181, China

Location

A O U Sant Orsola Malpighi

Bologna, 40138, Italy

Location

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

Location

Pratia Onkologia Katowice

Katowice, 40 519, Poland

Location

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

Kielce, 25-734, Poland

Location

Aidport Sp z o o

Skorzewo, 60-185, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

National Taiwan University Hospital

Taipei, 10043, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33382, Taiwan

Location

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

Ankara, 06200, Turkey (Türkiye)

Location

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

Ankara, 06620, Turkey (Türkiye)

Location

Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): December 29, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); TU (3); IT (1); PL (3); TW (2); CN (5); JP (3)