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CAR T-cell Therapy
JNJ-78278343 for Prostate Cancer
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 of 0 or 1
Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year and 10 months
Awards & highlights
Study Summary
This trial is testing a new drug to see what dose is safe and effective.
Who is the study for?
This trial is for men with advanced prostate cancer that has spread, who have already tried at least one type of hormone therapy or chemotherapy. They should be relatively healthy and active (ECOG status 0-1), not have major heart issues, clotting diseases, infections like hepatitis B/C or HIV, autoimmune diseases, lung problems, or any other cancers in the last two years.Check my eligibility
What is being tested?
The study is testing JNJ-78278343's optimal dose for safety and effectiveness in two parts: first finding the right dose (Dose Escalation) and then confirming its safety at this dose level (Dose Expansion).See study design
What are the potential side effects?
While specific side effects are not listed here, similar treatments often cause immune reactions since they target proteins on cancer cells which can affect normal cells too. This might lead to flu-like symptoms, fatigue, skin reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have not taken any cancer treatments for at least 2 weeks.
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My prostate cancer has spread to other parts of my body.
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My cancer can be measured or seen on tests.
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I have had treatment with a specific hormone therapy or chemotherapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year and 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year and 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 1 and 2: Number of Participants With AEs by Severity
Part 1 and 2: Number of Participants With Adverse Events (AEs)
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants With Anti-JNJ-78278343 Antibodies
Objective Response Rate (ORR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: JNJ-78278343Experimental Treatment1 Intervention
Participants will receive JNJ-78278343 either subcutaneously (SC injection or SC infusion) or intravenous (IV) infusion. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 either SC or IV at recommended phase 2 dose (RP2D) as determined in Part 1.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,527 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,960,113 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing hepatitis B or C infection.I have had a solid organ or bone marrow transplant.I have not been diagnosed with any cancer other than prostate cancer in the last 2 years.I am HIV positive but my viral load is undetectable due to stable antiretroviral therapy.I am fully active or can carry out light work.I have not taken any cancer treatments for at least 2 weeks.My prostate cancer has spread to other parts of my body.My cancer can be measured or seen on tests.I haven't had major blood clotting issues in the last month.I have taken immune-suppressing drugs within the last 3 days.I haven't had an autoimmune disease flare-up in the last year.I currently have an infection.I do not have any health issues that would prevent me from receiving the planned treatment.My cancer has spread to my brain or spinal cord.I have had my testicles removed or am on hormone therapy for cancer.I have been treated with a therapy targeting KLK2 before.I have had treatment with a specific hormone therapy or chemotherapy before.I have not had, nor plan to have, any live vaccines 4 weeks before starting the study drug.I haven't had major heart or blood vessel diseases in the last 6 months.I have a serious lung condition.I am still experiencing side effects from previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-78278343
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.
Is enrollment currently open for participation in this trial?
"As reported on clinicaltrials.gov, this research endeavour is in the process of sourcing participants. It was posted initially on July 13th 2021 and recently updated on November 22nd 2022."
Answered by AI
What ultimate effects are investigators hoping to observe with this clinical investigation?
"The principal purpose of this prolonged (over one year and ten months) clinical trial is to determine the occurrence rate of dose-limiting toxicity. Secondary objectives involve measuring serum concentrations of anti-JNJ78278343 antibodies, prostate specific antigen levels, as well as calculating PSA response rates by evaluating any decline from baseline values that are greater than 50%."
Answered by AI
How many participants have been recruited for this experiment?
"Affirmative. According to the clinicaltrials.gov, this medical study is actively recruiting subjects that meet the criteria it posted on July 13 2021 and updated on November 22 2022. The research project requires 110 patients from 3 sites for its completion."
Answered by AI
What potential risks are posed by JNJ-78278343?
"Due to the limited supporting evidence for JNJ-78278343's efficacy and safety, our team at Power judged it a score 1 on the scale of 1 to 3."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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