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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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen Mary University of London
Coordinator of this site? Confirm its status
Charterhouse SquareUnited KingdomUnknown status
Plymouth Hospitals NHS Trust
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PlymouthUnited KingdomUnknown status
Arensia Exploratory Medicine
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TbilisiGeorgiaUnknown status
ARENSIA Exploratory Medicine
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status
Pratia S.A.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
Coordinator of this site? Confirm its status
GdanskPolandCompleted
Pratia Hematologia Sp. Z o. o
Coordinator of this site? Confirm its status
KatowicePolandCompleted
Pratia S.A.
Coordinator of this site? Confirm its status
SkorzewoPolandCompleted
Chang-Gung Memorial Hospital, Kaohsiung
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Kaohsiung CountyTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Medical Center of Limited Liability Company Arensia Exploratory Medicine
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KyivUkraineUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.