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Monoclonal Antibodies

JNJ-64264681 for Non-Hodgkin's Lymphoma and Leukemia

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to treat B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Researchers will determine the best dosage of the drug and then study how safe it is.

Who is the study for?
This trial is for adults with certain types of blood cancers, like Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), able to follow the study rules, and have normal heart rhythm readings. Women must test negative for pregnancy and agree not to donate eggs during the study.Check my eligibility
What is being tested?
The trial is testing JNJ-64264681's safety and optimal dose in two parts: first finding the best dose, then checking its safety at that dose in patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).See study design
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions related to immune system activation, infusion-related symptoms, fatigue, digestive issues or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Secondary outcome measures
Complete Response (CR) Rate
Duration of Response (DOR)
Overall Response Rate (ORR)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: JNJ-64264681: Dose Escalation and ExpansionExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-64264681
2018
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,637 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,823 Total Patients Enrolled

Media Library

JNJ-64264681 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04210219 — Phase 1
Non-Hodgkin's Lymphoma Clinical Trial 2023: JNJ-64264681 Highlights & Side Effects. Trial Name: NCT04210219 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: JNJ-64264681: Dose Escalation and Expansion
JNJ-64264681 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04210219 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aspirations of this clinical research endeavor?

"The primary outcome of this clinical trial will be tracked over a span of up to 21 days and consists in the number of participants who experience adverse events (AEs). Secondary outcomes include blood concentrations of JNJ-64264681, percentage occupancy on target cells, as well as an overall response rate based on criteria established by the Revised Response Criteria for Malignant Lymphoma and International Workshops on Chronic lymphocytic leukemia (iwCLL) Response Criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) Response Criteria."

Answered by AI

Are participants still being accepted to take part in this medical experiment?

"The medical trial is open to applicants, with information regarding its initial posting on July 2nd of 2020 and the most recent update from November 3rd 2022 available via clinicaltrials.gov."

Answered by AI

What is the cap on participant enrollment for this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical study, which was first posted on July 2nd 2020, is actively recruiting. Approximately 108 participants need to be enrolled from just 1 site."

Answered by AI

What is the safety profile of JNJ-64264681 for patients?

"Due to the scarcity of data supporting the efficacy and safety of JNJ-64264681, it was assigned a score of 1."

Answered by AI
~30 spots leftby Apr 2026