A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

NCT04210219 | Completed Phase 1 FDA Drug

• 4 other identifiers: CR10870664264681LYM10012019-003194-252024-512686-13-00
• Study Type: interventional
• Target: 85
• Locations: 7 countries
• Sites: 15

Brief Summary

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.

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Plasma Concentration of JNJ-64264681

  Up to 2 years

• Percentage Occupancy of the Target

  Up to 2 years

• Overall Response Rate (ORR)

  Up to 2 years

• Time to Response (TTR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

Study Arms (1)

JNJ-64264681: Dose Escalation and Expansion

EXPERIMENTAL

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

Interventions

JNJ-64264681 DRUG

JNJ-64264681 capsule will be administered orally.

JNJ-64264681: Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (15)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Arensia Exploratory Medicine

Tbilisi, 0112, Georgia

Location

Arensia Exploratory Medicine

Chisinau, MD-2025, Moldova

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

Pratia Onkologia Katowice

Katowice, 40 519, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60 185, Poland

Location

Chang-Gung Memorial Hospital, Kaohsiung

Kaohsiung County, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Medical Center of Limited Liability Company Arensia Exploratory Medicine

Kyiv, 01135, Ukraine

Location

Queen Mary University of London

Charterhouse Square, EC1M 6BQ, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

JNJ-64264681

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 24, 2019
• Study Start: July 2, 2020
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1); GB (2); MO (1); PL (4); UA (1); GE (1); TW (5)