What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those involving monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, often result in infusion-related reactions. These reactions can include fever, chills, rash, and in severe cases, difficulty breathing and low blood pressure. Other side effects may include increased risk of infections, neutropenia, and fatigue. Immunotherapy treatments can also cause immune-related adverse effects such as colitis, hepatitis, and endocrinopathies. Adjustments in dosing schedules, especially during the initial cycles, can help mitigate some of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that target similar pathways to JNJ-80948543. Notably, anti-CD20 monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab have been widely used. These drugs target the CD20 protein on the surface of B-cells, leading to their destruction. Additionally, newer therapies like CAR T-cell treatments (e.g., axicabtagene ciloleucel and tisagenlecleucel) redirect T-cells to target and kill cancer cells. These treatments have shown efficacy in various subtypes of NHL and represent a significant advancement in the management of the disease.

What other types of research exist?

Promising alternatives to JNJ-80948543 for NHL patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown high response rates in relapsed/refractory NHL. 2) Bispecific antibodies like mosunetuzumab and glofitamab, which target CD20 and CD3, offering a novel mechanism similar to trispecific antibodies. 3) Lenalidomide-based regimens, which have demonstrated efficacy in combination with other agents for relapsed/refractory NHL. These therapies have shown promising results in terms of safety and efficacy in recent clinical trials.

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Monoclonal Antibodies

JNJ-80948543 for Lymphoma and Leukemia

Phase 1

Recruiting

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

Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy

Must not have

Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents within 1 year prior to first dose of study drug

Clinically significant pulmonary compromise requiring supplemental oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests JNJ-80948543, a new medicine that helps the immune system fight B-cell non-Hodgkin lymphoid malignancies. It works by connecting immune cells to cancer cells, aiding in their destruction. The study aims to find the best dose and schedule while monitoring safety and effectiveness over an extended period.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia who need treatment and have tried other therapies without success. They should be in good physical condition (ECOG Grade 0 or 1) and not pregnant, breastfeeding, or planning pregnancy soon. People with active brain involvement by cancer, recent organ transplants, autoimmune diseases needing strong medication within the last year, unresolved side effects from previous treatments (except certain stable conditions), or significant lung problems are excluded.

What is being tested?

The study tests JNJ-80948543, a new type of antibody designed to target cancer cells in two phases: first to find the safest dose (Part A) and then to confirm its safety at that dose in more people (Part B). It's given to patients whose disease has returned after treatment or hasn't responded well to existing options.

What are the potential side effects?

While specific side effects for JNJ-80948543 aren't listed here, similar cancer-targeting antibodies can cause immune reactions leading to inflammation in various organs including the liver and lungs, infusion-related reactions during administration of the drug, fatigue, blood cell count changes increasing infection risk among others.

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.

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I have B-cell NHL or CLL that needs treatment.

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My heart function is within the normal range.

Exclusion Criteria

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

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I haven't taken steroids or immunosuppressants for my autoimmune disease in the last year.

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I need extra oxygen to breathe properly.

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Side effects from my previous cancer treatments are mild or gone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 3 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

Number of Participants with AE by Severity

Number of Participants with Adverse Events (AEs)

Number of Participants with Dose-limiting Toxicity (DLT)

Secondary study objectives

Complete Response (CR) Rate

Duration of Response (DOR)

Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Cohort ExpansionExperimental Treatment1 Intervention

Participants will receive JNJ-80948543 by SC or IV administration.

Group II: Part A: Dose EscalationExperimental Treatment1 Intervention

Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.

0 / 6Eligibility 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 monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of lymphoma cells, leading to their destruction by the immune system. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancerous lymphocytes. Targeted therapies, like the trispecific antibody JNJ-80948543, are designed to engage multiple targets (e.g., CD79b, CD20, and CD3) to enhance the immune system's ability to recognize and kill lymphoma cells. These mechanisms are crucial for NHL patients as they offer more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional therapies.