What side effects are associated with this type of intervention?

Common treatments for metastatic castration-resistant prostate cancer (CRPC) include androgen deprivation therapy (ADT), abiraterone, enzalutamide, and chemotherapy agents like docetaxel and cabazitaxel. ADT can cause hot flashes, decreased libido, and osteoporosis. Abiraterone is associated with hypertension and hypokalemia. Enzalutamide may lead to fatigue, hypertension, and seizures. Chemotherapy agents like docetaxel and cabazitaxel can cause myelosuppression, neuropathy, and alopecia. These treatments have distinct side effect profiles that should be considered when making treatment decisions.

What prior FDA approvals exist?

FDA-approved treatments for metastatic castration-resistant prostate cancer (CRPC) include androgen receptor signaling inhibitors like enzalutamide and abiraterone, which help reduce androgen levels or block their effects. Chemotherapy agents such as docetaxel and cabazitaxel are also approved for CRPC. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has shown efficacy in PSMA-positive metastatic CRPC. Additionally, immunotherapy with sipuleucel-T is approved for certain CRPC patients. These treatments aim to manage disease progression and improve survival outcomes.

What other types of research exist?

Promising novel alternatives to JNJ-75229414 for prostate cancer patients include: 1) JNJ-63576253, a next-generation androgen receptor antagonist effective against wild-type and clinically relevant ligand binding domain mutations. 2) Abiraterone plus niraparib, particularly beneficial for patients with homologous recombination repair (HRR) alterations, as shown in the MAGNITUDE trial. 3) Abiraterone plus olaparib, which has demonstrated significant prolongation in median radiographic progression-free survival in the PROPEL trial. 4) Enzalutamide, which has shown adequate efficacy and safety in real-world conditions for Japanese patients with castration-resistant prostate cancer (CRPC).

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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)

Must not have

Prior Grade 4 Cytokine release syndrome (CRS) or Grade 3 or Grade 4 neurotoxicity related to any T cell redirection (Bispecific cluster of differentiation [CD 3])

Prior chimeric antigen receptor T cell (CAR-T) therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called JNJ-75229414 to find the safest and most effective dose for patients. The study will identify the best dose and ensure 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have experienced severe immune or nerve side effects from previous cancer treatment.

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I have previously received CAR-T cell therapy.

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I have previously received treatment targeting KLK2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

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

Prostate cancer treatments primarily target the androgen receptor pathway, which is crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor signaling inhibitors, like enzalutamide, block the receptor's activity, further inhibiting cancer growth. Chemotherapy agents, such as docetaxel, kill rapidly dividing cancer cells. Radiopharmaceuticals, like radium-223, deliver targeted radiation to bone metastases, reducing tumor burden and pain. Understanding these mechanisms helps patients and doctors choose the most effective treatment strategy, balancing efficacy and safety.

Symptomatic and quality-of-life outcomes after treatment for clinically localised prostate cancer: a systematic review.