A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Completed · Phase 1
Conditions studied: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
In brief
The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.
Key facts
- Study ID
- NCT04210219
- Run by
- Janssen Research & Development, LLC
- People needed
- 85
- Starts
- 2020-07-02
- Expected to finish
- 2025-05-28
- Last updated by the study team
- 2025-08-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) less than or equal to <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)
- Women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug
- Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration
- Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol
You may not qualify if…
- Participant has known active central nervous system (CNS) involvement
- Participant has received prior solid organ transplantation
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients
- Participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug
- Participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to Grade 1 or less (except for alopecia and peripheral neuropathy)
Where it is running
- Pratia Onkologia Katowice — Katowice, Poland
- Pratia MCM Krakow — Krakow, Poland
- Centrum Medyczne Pratia Poznan — Skorzewo, Poland
- Chang-Gung Memorial Hospital, Kaohsiung — Kaohsiung County, Taiwan
- China Medical University Hospital — Taichung, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan
- National Cheng Kung University Hospital — Tainan, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
- Medical Center of Limited Liability Company Arensia Exploratory Medicine — Kyiv, Ukraine
- Queen Mary University of London — Charterhouse Square, United Kingdom
- Plymouth Hospitals NHS Trust — Plymouth, United Kingdom
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Arensia Exploratory Medicine — Tbilisi, Georgia
- Arensia Exploratory Medicine — Chisinau, Moldova
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
Full record on ClinicalTrials.gov
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