What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly targeted therapies and immunotherapies similar to JNJ-64264681, often result in side effects such as partial alopecia, hair curling, and dyspigmentation. Immunotherapies can also cause patchy hypopigmentation of the skin and hair, as well as alopecia. Other frequent side effects include nausea, fatigue, and gastrointestinal issues. More severe toxicities can affect the hematologic, gastrointestinal, hepatic, and pulmonary systems, especially with aggressive treatments like hematopoietic cell transplantation.

What prior FDA approvals exist?

Several FDA-approved treatments for B cell Non-Hodgkin's Lymphoma (NHL) and chronic lymphocytic leukemia (CLL) target specific pathways or cells. Monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab target the CD20 antigen on B cells. Bruton tyrosine kinase (BTK) inhibitors like ibrutinib and acalabrutinib disrupt B cell receptor signaling. Venetoclax, a BCL-2 inhibitor, induces apoptosis in B cells. These therapies, similar to JNJ-64264681, focus on targeting specific components of the B cell pathway to treat NHL and CLL.

What other types of research exist?

Promising novel alternatives to JNJ-64264681 for Non-Hodgkin's Lymphoma patients include: 1) Second-generation BTK inhibitors such as acalabrutinib and zanubrutinib, which offer more selective targeting and potentially fewer side effects compared to first-generation inhibitors like ibrutinib. 2) Venetoclax, a BCL-2 inhibitor, which has shown high efficacy in achieving undetectable minimal residual disease (MRD) when used in combination with monoclonal antibodies like obinutuzumab. 3) Novel monoclonal antibodies and B-cell receptor signal transduction inhibitors, which are being integrated into risk-adapted treatment strategies to improve patient outcomes.

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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

Must not have

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 has known active central nervous system (CNS) involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called JNJ-64264681 to find the best dose and ensure it is safe. It focuses on patients with specific blood cancers, namely B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. The drug aims to attack and kill the cancer cells in these patients.

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.

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).

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

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs or vaccines within the last 2 weeks or five half-lives before starting the study drug.

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My cancer has spread to my brain or spinal cord.

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I am allergic to JNJ-64264681 or its ingredients.

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I still have side effects from cancer treatment, except for hair loss or nerve issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 and Part 2: Number of Participants with Adverse Events (AEs)

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Secondary study objectives

Complete Response (CR) Rate

Duration of Response (DOR)

Overall Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, kinase inhibitors, and immunotherapies. Monoclonal antibodies like rituximab target CD20 on B cells, leading to cell death. Kinase inhibitors, such as ibrutinib, block Bruton's tyrosine kinase (BTK), disrupting B cell receptor signaling and inducing apoptosis. Immunotherapies, including CAR-T cell therapy, modify a patient's T cells to target and kill lymphoma cells. These mechanisms are crucial for patients to understand as they explain how treatments work to control or eradicate the disease, aiding in better treatment outcomes and informed decision-making.