Trial Title:
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT ID:
NCT06470438
Condition:
Lymphoma, Non-Hodgkin
Refractory B-Cell NHL
Relapsed B-cell NHL
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-88998377
Description:
JNJ-88998377 will be administered.
Arm group label:
Part A: Dose Escalation
Arm group label:
Part B: Dose Expansion
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Facility:
Name:
A O U Sant Orsola Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Zip:
104 0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135 8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pratia Hematologia Sp z o o
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10043
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital
Address:
City:
Taoyuan
Zip:
33382
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara University Medical Faculty
Address:
City:
Ankara
Zip:
06590
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Koc University Medical Faculty
Address:
City:
Istanbul
Zip:
34010
Country:
Turkey
Status:
Recruiting
Start date:
May 28, 2024
Completion date:
October 29, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06470438
