Clinical Trials in South Korea / NCT06470438
Active, not recruiting
Phase 1
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT06470438 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Lymphoma, Non-HodgkinRefractory B-Cell NHLRelapsed B-cell NHL
Investigational drug(s) / intervention(s)
JNJ-88998377
JNJ-88998377: JNJ-88998377 will be administered.
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
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
Primary outcome measure(s)
- Parts A and B: Number of Participants with Adverse Events (AEs) — Upto 3 years 4 months
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. - Part A: Number of Participants with Dose Limiting Toxicity (DLTs) — Cycle 1 (21 days)
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.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Taiwan | |
| SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi | Ankara | Turkey (Türkiye) | |
| Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi | Ankara | Turkey (Türkiye) | |
| Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi | Istanbul | Turkey (Türkiye) |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06470438 on ClinicalTrials.gov ↗ ← All trials in South Korea