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NCT06236139 · ClinicalTrials.gov registry record · Phase 1

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Fred Hutchinson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT06236139 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 48 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06236139, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) still remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth an

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Bone Scan
  • BIOLOGICAL Anti-STEAP1 CAR T-cells

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2024-11-26
Est. Completion 2027-03-30
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT06236139

The ClinicalTrials.gov registry entry for NCT06236139 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (73% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06236139 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT06236139 about?

NCT06236139 is a clinical study titled "Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer". This phase I/II trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first...

What is the current status of trial NCT06236139?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-11-26. Estimated completion is 2027-03-30.

What conditions does trial NCT06236139 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma.

What interventions are being tested in trial NCT06236139?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Bone Scan (PROCEDURE), Anti-STEAP1 CAR T-cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT06236139?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06236139 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage IVB Prostate Cancer AJCC v8

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.