A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT Number: NCT06470438
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lymphoma, Non-Hodgkin|Refractory B-Cell NHL|Relapsed B-cell NHL
Interventions: DRUG: JNJ-88998377
Sponsor: Janssen Research & Development, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2027-10-29
Locations: A O U Sant Orsola Malpighi, Bologna, 40138, Italy|The Cancer Institute Hospital of JFCR, Tokyo, 135 8550, Japan|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Pratia Hematologia Sp z o o, Katowice, 40-519, Poland|Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce, 25-734, Poland|National Taiwan University Hospital, Taipei, 10043, Taiwan|Linkou Chang Gung Memorial Hospital, Taoyuan, 33382, Taiwan|Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, 06200, Turkey|Ankara University Medical Faculty, Ankara, 06590, Turkey|Koc University Medical Faculty, Istanbul, 34010, Turkey

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) and to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).

Primary Outcome Measures: 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: 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)