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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 2 years 5 months
Awards & highlights

Summary

This trial is investigating a new drug, JNJ-80948543, to see if it is safe and effective. Part A is testing different doses to see what the best dose is. Part B is testing the safety of the best dose found in Part A.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with AE by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose-limiting Toxicity (DLT)
Secondary outcome measures
Complete Response (CR) Rate
Duration of Response (DOR)
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Cohort ExpansionExperimental Treatment1 Intervention
Participants will receive JNJ-80948543 by SC administration.
Group II: Part A: Dose EscalationExperimental Treatment1 Intervention
Participants will receive JNJ-80948543 by subcutaneous (SC) administration to determine the putative recommended Phase 2 dose (RP2D) and dosing schedule(s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.

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.

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,073 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,727 Total Patients Enrolled

Media Library

JNJ-80948543 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05424822 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Part A: Dose Escalation, Part B: Cohort Expansion
Non-Hodgkin's Lymphoma Clinical Trial 2023: JNJ-80948543 Highlights & Side Effects. Trial Name: NCT05424822 — Phase 1
JNJ-80948543 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424822 — Phase 1
~0 spots leftby Jul 2024