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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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 48 hours postdose (up to 2 years 10 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 48 hours postdose (up to 2 years 10 months)
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 moreTrial 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.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,161 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,758 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stem cell transplant recently or need immunosuppressants due to graft versus host disease.I haven't had cancer, other than skin or cervical cancer, in the last year.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatments excluding minor radiation, for at least 2 weeks or 5 half-lives of the drug, whichever is longer.I am either not able to have children or I use a very effective birth control method and agree to continue using it during the study and for 90 days after.My lymphoma has spread to my brain or spinal cord.I am on medication for an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Escalation
- Group 2: Part B: Cohort Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current recruitment number for this clinical experiment?
"Affirmative. According to the clinicaltrials.gov website, this trial posted on November 20th 2020 is actively recruiting patients for participation. The study requires 120 individuals from 4 distinct sites in order to proceed as planned."
Answered by AI
What is the main objective of this research?
"The primary endpoint of this medical trial, which will be monitored for a period up to two years and ten months, is the number of participants experiencing dose-limiting toxicity. Secondary endpoints include duration of response (DOR), time to response (TTR) and Minimum Observed Serum Concentration (Cmin)of JNJ-75348780."
Answered by AI
Is there an opportunity to join this research project at present?
"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial is currently open for enrolment; the initial post was on November 20th 2020, and the study has been updated as of November 3rd 2022. A total of 120 participants have to be recruited from 4 distinct medical sites."
Answered by AI
Has the FDA affirmed JNJ-75348780 for use?
"Our team at Power assigned JNJ-7534870 a score of 1 because it is currently being tested in Phase 1 clinical trials. As such, there is minimal data supporting the safety and efficacy of this drug."
Answered by AI
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