Clinical trial NCT06470438: A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Refractory B-Cell NHL
Relapsed B-cell NHL
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 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

Primary outcomes:
measure: Parts A and B: Number of Participants with Adverse Events (AEs)
timeFrame: Upto 3 years 4 months
measure: Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
timeFrame: Cycle 1 (21 days)
Secondary outcomes:
measure: Plasma Concentration of JNJ-88998377
timeFrame: Up to first 12 weeks
measure: Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
timeFrame: Up to first 12 weeks
measure: Maximum Plasma Concentration (Cmax) of JNJ-88998377
timeFrame: Up to first 12 weeks
measure: Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
timeFrame: Up to first 12 weeks
measure: Percentage of Participants With Overall Response (OR)
timeFrame: Up to 3 years 4 months
measure: Time to Response (TTR)
timeFrame: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
measure: Duration of Response (DOR)
timeFrame: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Hang Zhou Shi
country: China
facility: The First Affiliated Hospital Zhejiang University College of Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
city: Skorzewo
country: Poland
facility: Aidport Sp z o o
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Koc University Medical Faculty
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: