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Monoclonal Antibodies

JNJ-75348780 for 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
Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 48 hours postdose (up to 2 years 10 months)
Awards & highlights

Study Summary

This trial is testing a new drug for people with relapsed or refractory B-cell NHL or CLL. The goal is to find the best dose and schedule for the drug and to characterize its safety.

Who is the study for?
This trial is for adults with B-cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia that's come back or hasn't responded to treatment. They should have tried other approved treatments without success and must not be pregnant, agree to use effective contraception, and be in good physical condition (ECOG Grade 0 or 1).Check my eligibility
What is being tested?
The study tests JNJ-75348780's safety and optimal dose for patients with specific types of lymphomas and leukemia. Part A determines the best dose while Part B further examines its safety at this established dose.See study design
What are the potential side effects?
While the side effects are being characterized in this study, potential risks may include typical reactions to new cancer drugs such as immune system effects, infusion-related reactions, fatigue, nausea, and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 48 hours postdose (up to 2 years 10 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 48 hours postdose (up to 2 years 10 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
Part A and Part B: Number of Participants with AEs by Severity
Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780
Complete Response (CR) Rate
Duration of Response (DOR)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Cohort ExpansionExperimental Treatment1 Intervention
Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.
Group II: Part A: Dose EscalationExperimental Treatment1 Intervention
Participants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.

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, bind to specific antigens on lymphoma cells, triggering immune responses that lead to cell death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like kinase inhibitors, disrupt specific molecular pathways critical for cancer cell survival and growth. These mechanisms are important for NHL patients as they allow for tailored treatment approaches that can enhance effectiveness and reduce adverse effects.
[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
979 Previous Clinical Trials
6,384,973 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
748 Previous Clinical Trials
3,960,551 Total Patients Enrolled

Media Library

JNJ-75348780 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04540796 — 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-75348780 Highlights & Side Effects. Trial Name: NCT04540796 — Phase 1
JNJ-75348780 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540796 — Phase 1
~25 spots leftby Apr 2025