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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
• Intervention / Treatment: Drug: JNJ-64264681

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0112
    • ARENSIA Exploratory Medicine
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD-2025
    • ARENSIA Exploratory Medicine
• Poland
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40 519
    • Pratia Onkologia Katowice
  • Krakow, Poland, 30-727
    • PRATIA MCM Kraków
  • Skorzewo, Poland, 60 185
    • Centrum Medyczne Pratia Poznań
• Taiwan
  • Kaohsiung County, Taiwan, 83301
    • Chang-Gung Memorial Hospital, Kaohsiung
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 40402
    • China Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
• Ukraine
  • Kyiv, Ukraine, 01135
    • Medical Center of Limited Liability Company Arensia Exploratory Medicine
• United Kingdom
  • Charterhouse Square, United Kingdom, EC1M 6BQ
    • Queen Mary University of London
  • Plymouth, United Kingdom, PL6 8DH
    • Plymouth Hospitals NHS Trust
• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: JNJ-64264681: Dose Escalation and Expansion; Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).

Drug: JNJ-64264681; JNJ-64264681 capsule will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).	Up to 21 days
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of JNJ-64264681	Plasma concentration of JNJ-64264681 will be evaluated.	Up to 2 years
Percentage Occupancy of the Target	The pharmacodynamics of JNJ-64264681 will be assessed by determining the percentage of target occupancy. Blood samples will be obtained for pharmacodynamic assessments (target occupancy).	Up to 2 years
Overall Response Rate (ORR)	ORR is defined as the percentage of participants who achieve a complete response (CR) + partial response (PR) or better according to the Revised Response Criteria for Malignant Lymphoma and the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Response Criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) Response Criteria.	Up to 2 years
Time to Response (TTR)	TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.	Up to 2 years
Duration of Response (DOR)	DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.	Up to 2 years
Complete Response (CR) Rate	CR rate is defined as the percentage of participants who achieve a best response of CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.	Up to 2 years
Progression-free Survival (PFS)	PFS is defined as the time from the date of the first dose of the study drug to the date of either the first documented disease progression (according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria), or death due to any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Lymphoma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CR108706; 2019-003194-25 (EudraCT Number); 64264681LYM1001 (Other Identifier: Janssen Research & Development, LLC); 2024-512686-13-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No