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A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants

A Phase 1, Dose Escalation Study of JNJ-75229414, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against KLK2 for Metastatic Castration-Resistant Prostate Cancer

NCT05022849•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine recommended Phase 2 dose (RP2D) regimen(s) of JNJ-75229414 in Part 1 (Dose Escalation and to determine safety at the RP2D regimen(s) in Part 2 (Dose Expansion).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histology: Metastatic CRPC (mCRPC) with histologic confirmation of adenocarcinoma. Metastatic CRPC with neuroendocrine features or mixed histology is excluded
•Prior Therapy: Prior treatment with at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or at least 1 prior chemotherapy (example, docetaxel)
•Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
•Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
•Fertile participants must use a condom with spermicide during any sexual contact with a woman of childbearing potential, including pregnant women, from the time of signing the ICF until 1 year after receiving a JNJ-75229414 infusion. Vasectomized participants must agree to use a condom to protect any sexual partner from exposure to semen for 1 year after receiving the last dose of study drug. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies

Exclusion Criteria

•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 Kallikrein 2 (KLK2)-targeted therapy
•Prior chimeric antigen receptor T cell (CAR-T) therapy
•Receiving systemic treatment less than or equal to (\<=) 6 months prior to signing informed consent) for any invasive malignancy other than prostate cancer unless approved by the sponsor. Bisphosphonates initiated greater than or equal to (\>=) 6 weeks prior signing informed consent are allowed
•Less than 2 weeks between last administration anti-androgen agents (example, abiraterone or enzalutamide), poly adenosine diphosphate-ribose polymerase (PARP) inhibitors (example, olaparib) or radiotherapy, and less than 3 weeks between last administration of cytotoxic chemotherapy (example, docetaxel), radionuclides (example, radium-223, lutetium-177-Prostate-specific membrane antigen \[PSMA\]-617) or an investigational agent, and apheresis

Locations (8)

City of Hope Cancer Center

Duarte, California, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

September 28, 2021

Primary Completion Date

October 30, 2037

Completion Date

October 30, 2037

Last Updated

March 13, 2026

Enrollment

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

JNJ-75229414

DRUG

Bridging Therapy

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

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Clinical Application of the J-PET Scanner Prototype