Testing JNJ-88998377 for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
This study is testing a new drug called JNJ-88998377 to see if it is safe and what the best dose is for people with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 19 sites (Beijing and 18 other locations) |
| Trial ID | NCT06470438 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and determine the recommended phase 2 dose (RP2D) of JNJ-88998377 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. The trial consists of two parts: Part A focuses on dose escalation to identify the RP2D, while Part B assesses the safety of JNJ-88998377 at this determined dose. Participants will be monitored for measurable disease and must meet specific health criteria to ensure their eligibility for the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed relapsed or refractory B-cell non-Hodgkin's lymphoma who meet specific health criteria.
Not a fit: Patients with active or prior central nervous system involvement or other malignancies within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promise with similar approaches in treating B-cell non-Hodgkin's lymphoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing and 18 other locations
- Beijing Cancer Hospital — Beijing, China (Recruiting)
- Sun Yat Sen University Cancer Center — Guangzhou, China (Recruiting)
- The First Affiliated Hospital Zhejiang University College of Medicine — Hang Zhou Shi, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
- A O U Sant Orsola Malpighi — Bologna, Italy (Recruiting)
- National Cancer Center Hospital — Chuo Ku, Japan (Completed)
- National Cancer Center Hospital East — Kashiwa, Japan (Recruiting)
- The Cancer Institute Hospital of JFCR — Tokyo, Japan (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Pratia Onkologia Katowice — Katowice, Poland (Recruiting)
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku — Kielce, Poland (Recruiting)
- Aidport Sp z o o — Skorzewo, Poland (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital — Ankara, Turkey (Recruiting)
- Ankara University Medical Faculty — Ankara, Turkey (Recruiting)
- Koc University Medical Faculty — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.