Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptors in Treating Patients With Locally Advanced and Unresectable or Metastatic Small Cell Neuroendocrine Prostate Cancer

Summary

This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ lentivirally transduced to express L1CAM-specific chimeric antigen receptor (CAR) and EGFRt mutation specific T cells and to see how well they work in treating patients with small cell neuroendocrine prostate cancer (SCNPC) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). 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 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. Some solid tumor cells have an L1CAM protein on their surface, and T cells can be modified with a receptor, called a chimeric antigen receptor (CAR), to help recognize this protein and kill these tumor cells. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. These L1CAM mutation specific T cells may help the body's immune system identify and kill L1CAM locally advanced and unresectable or metastatic small cell neuroendocrine prostate cancers' tumor cells.

Conditions

• Prostate Carcinoma
• Prostate Small Cell Neuroendocrine Carcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

DRUG

Bendamustine

Given IV

PROCEDURE

Biopsy

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Bridge Therapy

Undergo bridging therapy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

T-cell Receptor-engineered T-cells

Given autologous L1CAM-specific CAR+EGFRt+ T cells IV

PROCEDURE

X-Ray Imaging

Undergo chest x-ray

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Michael Schweizer · 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

2025-04-15

Primary Completion

2028-03-15

Completion

2028-03-15

FDA Drug

Yes

Countries

• United States

Study Locations