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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05022849
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: JNJ-75229414 Drug: Bridging Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : July 3, 2024
Estimated Study Completion Date : December 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
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.
Drug: JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
Other Name: KLK2 CAR-T Cells

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

Experimental: Part 2: Dose Expansion
Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.
Drug: JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
Other Name: KLK2 CAR-T Cells

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




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 2 years and 10 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 2 years and 10 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 Outcome Measures :
  1. Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414 [ Time Frame: Up to 2 years and 10 months ]
    Cmax is the maximum observed plasma concentration of JNJ-75229414.

  2. Time to Reach Maximum Observe Plasma Concentration (Tmax) of JNJ-75229414 [ Time Frame: Up to 2 years and 10 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 2 years and 10 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 2 years and 10 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 2 years and 10 months ]
    Number of participants with antibodies to JNJ-75229414 will be reported.

  6. Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 10 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 2 years and 10 months ]
    DCR is defined as the sum of CR, PR, and stable disease (SD).

  8. Duration of Response (DoR) [ Time Frame: Up to 2 years and 10 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 2 years and 10 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 2 years and 10 months ]
    Peripheral blood quantitation of VSV-G copy numbers will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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) or radiotherapy, and less than 3 weeks between last administration of cytotoxic chemotherapy (example, docetaxel) or an investigational agent, and apheresis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022849


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, California
City of Hope Cancer Center Recruiting
Duarte, California, United States, 91010
Cedars-Sinai Medical Center Not yet recruiting
West Hollywood, California, United States, 90048
United States, Georgia
Emory University - Winship Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30322
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Michigan
Barbara Ann Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05022849    
Other Study ID Numbers: CR108972
75229414MPC1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases