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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05022849
• Other study ID #: CR108972
• Secondary ID: 75229414MPC1001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 28, 2021
• Est. completion date: June 30, 2037

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 30, 2037
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
• 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.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	City of Hope Cancer Center	Duarte	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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.	Up to 15 years 9 months
Primary	Number of Participants with AEs by Severity	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.	Up to 15 years 9 months
Primary	Part 1: Number of Participants with Dose-limiting Toxicity (DLT)	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.	Up to 28 days
Secondary	Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414	Cmax is the maximum observed plasma concentration of JNJ-75229414.	Up to 15 years 9 months
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75229414	Tmax is the actual sampling time to reach maximum observed plasma concentration of JNJ-75229414.	Up to 15 years 9 months
Secondary	Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414	AUC(0-t) is the area under the plasma concentration versus time curve from time zero to 't' time.	Up to 15 years 9 months
Secondary	Peripheral T Cell Expansion and Persistence via Monitoring Chimeric Antigen Receptor T (CAR-T) Positive Cell Counts	Peripheral T cell expansion and persistence via monitoring CAR-T positive cell counts will be reported.	Up to 15 years 9 months
Secondary	Number of Participants With Presence of Anti-JNJ-75229414 Antibodies	Number of participants with antibodies to JNJ-75229414 will be reported.	Up to 15 years 9 months
Secondary	Overall Response Rate (ORR)	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.	Up to 15 years 9 months
Secondary	Disease Control Rate (DCR)	DCR is defined as the sum of CR, PR, and stable disease (SD).	Up to 15 years 9 months
Secondary	Duration of Response (DoR)	DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.	Up to 15 years 9 months
Secondary	Time to response (TTR)	TTR defined as the time from the date of first dose of study drug to the date of first documented response.	Up to 15 years 9 months
Secondary	Peripheral Blood Quantitation of Vesicular Stomatitis Virus G glycoprotein (VSV-G) Copy Numbers	Peripheral blood quantitation of VSV-G copy numbers will be reported.	Up to 15 years 9 months