IL-18 Armored STEAP1 CAR T Cells for the Treatment of Metastatic Castration Resistant Prostate Cancer

Summary

This phase I trial tests the safety, side effects, best dose and how well giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy (with cyclophosphamide and fludarabine) works for the treatment of castration resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Giving chemotherapy, with cyclophosphamide and fludarabine, prior to CAR T cells helps kill cancer cells in the body and prepare the body to receive the CAR T cells. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer 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 cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy may be safe, tolerable and/or effective in treating patients with metastatic castration resistant prostate cancer.

Conditions

• Metastatic Castration-Resistant Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

BIOLOGICAL

FH-STEAP1 IL-18 CAR T cells

Given FH-STEAP1 IL-18 CAR T cells IV

DRUG

Antiandrogen Therapy

Receive standard of care androgen deprivation therapy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo nuclear medicine bone scan

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Positron Emission Tomography

Undergo PET scan

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

Sponsors & Collaborators

• PromiCell Therapeutics, Inc.

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rosa Nadal Rios, MD, PhD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2030-10-31

Completion

2044-10-31

FDA Drug

Yes

Countries

• United States

Study Locations