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Monoclonal Antibodies

JNJ-80948543 for Lymphoma and Leukemia

Q: How many individuals have volunteered to take part in this experiment?

<p>Janssen Research &#x26; Development, LLC is leading the study which requires 180 participants with suitable inclusion criteria. This medical trial will be administered at multiple sites such as The University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> MD Anderson <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Houston and Seattle Cancer Care Alliance in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> State.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 5 months

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 5 months

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

977 Previous Clinical Trials

6,384,794 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,372 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

Frequently Asked Questions

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

Are there any openings available to join this medical experiment?

"According to its listing on clinicaltrials.gov, this experiment is still in search of participants. It was first listed on the 18th of August 2022 and its details were last revised December 1st that same year."

Answered by AI

Has JNJ-80948543 attained regulatory authorization from the Federal Drug Administration?

"The safety of JNJ-80948543 has been rated as a 1, due to the scarcity of clinical data attesting its efficacy and reliability. This is typical for Phase 1 trials."

Answered by AI

What is the primary objective of this medical experiment?

"This long-term clinical trial, stretching 2 years and 5 months, will focus on collecting data concerning the number of participants affected by Adverse Events (AEs). Additional objectives include determining Duration of Response (DOR), Time to Response (TTR), and Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)."

Answered by AI

In what geographic locations are the trials of this research taking place?

"Six centres are currently running the clinical trial in question, some of which include The University of Texas MD Anderson Cancer Center (Houston), Seattle Cancer Care Alliance (Seattle) and City of Hope (Duarte)."

Answered by AI

How many individuals have volunteered to take part in this experiment?

"Janssen Research & Development, LLC is leading the study which requires 180 participants with suitable inclusion criteria. This medical trial will be administered at multiple sites such as The University of Texas MD Anderson Cancer Center in Houston and Seattle Cancer Care Alliance in Washington State."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

2022. "A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424822.

All > Cll > Chronic Lymphocytic Leukemia