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Completed

NCT Number: NCT05022849

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

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).

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope Cancer Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-75229414

Drug

JNJ-75229414 infusion will be administered intravenously.

Other names: KLK2 CAR-T Cells

Bridging Therapy

Drug

Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 15 years 9 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

  2. Number of Participants with AEs by Severity

    Time frame: Up to 15 years 9 months

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  3. Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

    Time frame: Up to 28 days

    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

Secondary outcomes

  1. Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414

    Time frame: Up to 15 years 9 months

    Cmax is the maximum observed plasma concentration of JNJ-75229414.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75229414

    Time frame: Up to 15 years 9 months

    Tmax is the actual sampling time to reach maximum observed plasma concentration of JNJ-75229414.

  3. Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414

    Time frame: Up to 15 years 9 months

    AUC(0-t) is the area under the plasma concentration versus time curve from time zero to 't' time.

  4. Peripheral T Cell Expansion and Persistence via Monitoring Chimeric Antigen Receptor T (CAR-T) Positive Cell Counts

    Time frame: Up to 15 years 9 months

    Peripheral T cell expansion and persistence via monitoring CAR-T positive cell counts will be reported.

  5. Number of Participants With Presence of Anti-JNJ-75229414 Antibodies

    Time frame: Up to 15 years 9 months

    Number of participants with antibodies to JNJ-75229414 will be reported.

  6. Overall Response Rate (ORR)

    Time frame: Up to 15 years 9 months

    ORR is defined as the percentage of participants who achieve a confirmed best overall response of Complete Response (CR) or Partial Response (PR) evaluated by an independent local radiology review based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Prostate Cancer Working Group 3 (PCWG3) criteria will be used to assess progressive bone metastases.

  7. Disease Control Rate (DCR)

    Time frame: Up to 15 years 9 months

    DCR is defined as the sum of CR, PR, and stable disease (SD).

  8. Duration of Response (DoR)

    Time frame: Up to 15 years 9 months

    DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.

  9. Time to response (TTR)

    Time frame: Up to 15 years 9 months

    TTR defined as the time from the date of first dose of study drug to the date of first documented response.

  10. Peripheral Blood Quantitation of Vesicular Stomatitis Virus G glycoprotein (VSV-G) Copy Numbers

    Time frame: Up to 15 years 9 months

    Peripheral blood quantitation of VSV-G copy numbers will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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