What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly targeted therapies for B-cell malignancies like JNJ-67856633, include monoclonal antibodies (e.g., rituximab), kinase inhibitors (e.g., idelalisib), and combination regimens (e.g., bendamustine with rituximab). Known side effects of these treatments can include infusion reactions, which are more severe during the first cycle, especially with high white blood cell counts. Other side effects may include hematologic toxicities (e.g., neutropenia, thrombocytopenia), gastrointestinal issues (e.g., nausea, diarrhea), hepatic toxicity, and increased risk of infections. Adjustments in dosing schedules are often made to mitigate these side effects.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL), particularly B-cell malignancies, include targeted therapies such as Rituximab, which targets the CD20 protein on B-cells, and Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor. Venetoclax, a BCL-2 inhibitor, is another approved drug for relapsed or refractory B-cell NHL. These therapies have been pivotal in managing B-cell NHL and are similar in approach to the investigational drug JNJ-67856633, which is being studied for its efficacy in relapsed or refractory B-cell NHL and chronic lymphocytic leukemia.

What other types of research exist?

Promising novel alternatives to JNJ-67856633 for NHL patients include: 1) Copanlisib, a PI3K inhibitor, which has shown efficacy in relapsed/refractory indolent NHL. 2) CAR T-cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel, which target BCMA. 3) Bispecific T cell engagers (BiTEs) like teclistamab, which target CD3 and BCMA. 4) Novel agents targeting cereblon, such as iberdomide. These therapies have demonstrated significant potential in clinical trials and may offer effective treatment options in 2024.

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Monoclonal Antibodies

JNJ-67856633 for Lymphoma and Leukemia

Q: What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells. Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on the surface of cancer cells, marking them for destruction by the immune system. Targeted therapies, like the investigational drug JNJ-67856633, focus on specific molecular targets involved in the growth and survival of cancer cells. For instance, Bruton tyrosine kinase (BTK) inhibitors block signals that promote B-cell malignancies. These targeted approaches are crucial for NHL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving overall outcomes and quality of life.

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

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Be older than 18 years old

Must not have

Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor

Either of the following: a) Received an autologous stem cell transplant <=3 months before the first dose of study drug. b) Prior treatment with allogenic stem cell transplant <=6 months before the first dose of study drug, has evidence of graft versus host disease, or requires immunosuppressant therapy for graft versus host disease within the last 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years and 11 months

Awards & highlights

Summary

This trial tests JNJ-67856633, an oral drug, in patients with certain blood cancers that have returned or resisted treatment. The drug works by blocking a protein that helps cancer cells grow. The study aims to find the safest dose and see if the drug is effective.

Who is the study for?

This trial is for adults with certain types of blood cancer, like Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia that has come back or didn't respond to treatment. They should have a heart rhythm within normal limits and be able to do most daily activities on their own. Women must test negative for pregnancy and both men and women need to use reliable birth control.

What is being tested?

The study is testing the safety and best dose of a new drug called JNJ-67856633 in patients whose blood cancers have returned after treatment or haven’t responded at all. The goal is to find the highest dose patients can take without too many side effects.

What are the potential side effects?

Specific side effects of JNJ-67856633 are not listed, but common ones for cancer treatments include nausea, fatigue, risk of infection, allergic reactions, and changes in blood counts. Side effects depend on how much medicine you get.

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 can carry out light work.

Exclusion Criteria

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

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I have been treated with a MALT1 inhibitor before.

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I had a stem cell transplant recently and may have graft versus host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 11 months 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) as a Measure of Safety and Tolerability

Part 1: Dose-Limiting Toxicity (DLT)

Secondary study objectives

JNJ-67856633 Plasma Concentrations

Part 1 and Part 2: Complete Response Rate

Part 1 and Part 2: Duration of Response (DoR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (Cohort Expansion): JNJ-67856633Experimental Treatment1 Intervention

Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Group II: Part 1 (Dose Escalation): JNJ-67856633Experimental Treatment1 Intervention

Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

0 / 3Eligibility 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

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells. Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on the surface of cancer cells, marking them for destruction by the immune system. Targeted therapies, like the investigational drug JNJ-67856633, focus on specific molecular targets involved in the growth and survival of cancer cells. For instance, Bruton tyrosine kinase (BTK) inhibitors block signals that promote B-cell malignancies. These targeted approaches are crucial for NHL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving overall outcomes and quality of life.