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CAR T-cell Therapy

JNJ-75229414 for Prostate Cancer

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
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
Prior Therapy: Prior treatment with at least 1 prior novel androgen receptor AR-targeted therapy (abiraterone acetate, apalutamide, enzalutamide, darolutamide), or at least 1 prior chemotherapy (docetaxel)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years 9 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the best dosage is and if it is safe.

Who is the study for?
This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They should have tried at least one other treatment like abiraterone or chemotherapy, be relatively healthy (ECOG grade 0 or 1), and either have measurable disease or detectable PSA levels. Men must use contraception during the study.Check my eligibility
What is being tested?
The trial is testing JNJ-75229414's safety and optimal dose in two parts: first finding the best dose, then seeing how safe it is at that dose. It includes a bridging therapy phase where patients transition from their previous treatments.See study design
What are the potential side effects?
Potential side effects may include severe immune reactions like cytokine release syndrome, which can cause fever and fatigue, as well as possible nerve-related issues due to T cell redirection therapies used in the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by scans or has detectable PSA levels.
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I have previously been treated with specific prostate cancer medications or chemotherapy.
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I am fully active or can carry out light work.
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My prostate cancer has spread, and it's confirmed to be adenocarcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years 9 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 Adverse Events (AEs)
Number of Participants with AEs by Severity
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Secondary outcome measures
Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414
Disease Control Rate (DCR)
Duration of Response (DoR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.
Group II: Part 1: Dose EscalationExperimental Treatment2 Interventions
Participants will receive a conditioning regimen of cyclophosphamide and fludarabine intravenously (IV) followed by JNJ-75229414 IV infusion escalated sequentially with a targeted dose consistent with the dose required by the cohort being enrolled to determine recommended Phase 2 dose (RP2D) regimen(s). Additional, intermediate dose levels may be implemented based on the review of all available data including, but not limited to, safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) by the study evaluation team (SET). Participants may receive bridging therapy (anti-androgen receptor agents [example, abiraterone, enzalutamide] and radiotherapy, or chemotherapy [example, docetaxel]) if clinically indicated to maintain disease stability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bridging Therapy
2019
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,293 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
745 Previous Clinical Trials
3,959,890 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Media Library

JNJ-75229414 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05022849 — Phase 1
Prostate Cancer Research Study Groups: Part 1: Dose Escalation, Part 2: Dose Expansion
Prostate Cancer Clinical Trial 2023: JNJ-75229414 Highlights & Side Effects. Trial Name: NCT05022849 — Phase 1
JNJ-75229414 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022849 — Phase 1

Frequently Asked Questions

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

Is this research project recruiting participants at this time?

"According to clinicaltrials.gov, the search for participants is still ongoing since its initial listing on September 28th 2021 and last update on November 22nd 2022."

Answered by AI

What primary endpoints is this clinical trial attempting to identify?

"This clinical trial, which will run for a maximum of 28 days, aims to quantify the number of adverse events (AEs) according to severity. Secondary objectives include measuring Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]), ascertaining the presence of Anti-JNJ-75229414 Antibodies in participants, and calculating Overall Response Rate (ORR), with Prostate cancer Working Group 3 (PCWG3) criteria being applied when assessing progressive bone metastases."

Answered by AI

What potential adverse effects are associated with JNJ-75229414 administration?

"JNJ-75229414 is a still in initial testing, so it was assigned a safety rating of 1. This Phase 1 trial has very little data to support its efficacy and safety efficacy."

Answered by AI

What is the scope of individuals involved in this experiment?

"Indeed, according to information sourced from clinicaltrials.gov, this experiment is currently recruiting subjects. The trial was first published on September 28th 2021 and recently updated on November 22nd 2022. There are 10 different sites looking for 40 participants alltogether."

Answered by AI

To what extent has this clinical trial been implemented in medical facilities?

"This trial is currently running in 10 distinct locations. Among them are New york, West Hollywood and Salt Lake City as well as an additional 7 sites. To reduce travel demands, it is suggested to choose the closest one if you decide to enroll in the study."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Barbara Ann Karmanos Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants
2021. "A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05022849.
All > Prostate Cancer High Point > Prostate Cancer
~1 spots leftby Jul 2024
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