A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
- Conditions
- Refractory B-Cell NHLRelapsed B-cell NHLLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT06470438
- Lead Sponsor
- Janssen Research & Development, LLC
- 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) and to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 as malignancies can interfere with study endpoints
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Dose Escalation JNJ-88998377 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). Part B: Dose Expansion JNJ-88998377 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Overall Response (OR) Up to 3 years 4 months 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.
Time to Response (TTR) From first dose of study treatment until first response of PR or better (up to 3 years and 4 months) 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.
Duration of Response (DOR) From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months) 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.
Plasma Concentration of JNJ-88998377 Up to first 12 weeks Plasma concentration of oral dose of JNJ-88998377 will be assessed.
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377 Up to first 12 weeks Cmin of JNJ-88998377 will be reported.
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377 Up to first 12 weeks Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.
Maximum Plasma Concentration (Cmax) of JNJ-88998377 Up to first 12 weeks Cmax of JNJ-88998377 will be reported.
Trial Locations
- Locations (19)
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, China
Beijing Cancer Hospital
🇨🇳Beijing, China
The First Affiliated Hospital Zhejiang University College of Medicine
🇨🇳Hang Zhou Shi, 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
Aidport Sp z o o
🇵🇱Skorzewo, Poland
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Koc University Medical Faculty
🇹🇷Istanbul, Turkey
National Cancer Center Hospital
🇯🇵Chuo Ku, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Pratia Onkologia Katowice
🇵🇱Katowice, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
🇵🇱Kielce, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan