NCT04210219CompletedPhase 1
A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 21 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 85 (actual)
- First submitted
- 23 Dec 2019
- Start date
- 2 Jul 2020
- Primary completion date
- 28 May 2025
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT04210219
- EU CT number
- 2024-512686-13-00
- EudraCT number
- 2019-003194-25
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 85
- From 2 Jul 2020 to the primary completion date, 28 May 2025
- 15 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received prior solid organ transplantation
- 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)
Other illness
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients
Other
- Participant has known active central nervous system (CNS) involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary University of London Coordinator of this site? Confirm its status | Charterhouse Square | United Kingdom | Unknown status |
| Plymouth Hospitals NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Skorzewo | Poland | Completed |
| Chang-Gung Memorial Hospital, Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung County | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Medical Center of Limited Liability Company Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.