WithdrawnPhase 1

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

Stopped: Study closed before opening to accrual

United States0Started 2025-04-15

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must be ≥ 18 years of age * Able to understand and give written informed consent * Confirmation of small cell neuroendocrine prostate cancer (SCNPC) diagnosis by internal pathology review of initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Center/University of Washington * Previously treated with a platinum-based chemotherapy regimen for SCNPC * Participants may not have received prior therapy or plan to receive therapy (chemotherapy, immunotherapy and/or radiation therapy) or have undergone or plan to undergo major surgery within the last 3 weeks prior to leukapheresis AND initiation of lymphodepleting chemotherapy. Participants who have developed SCNPC in the context of prior androgen deprivation therapy (ADT) (i.e. medical/surgical castration) may continue on ADT at the discretion of their treating provider * Evidence of L1CAM positivity by immunohistochemistry review of the patient's archival/fresh tumor samples * Metastatic or locally advanced and unresectable disease * Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0 or 1) * Expected survival \> 3 months * Fertile participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the CAR T cell infusion * Measurable disease per RECIST v1.1 criteria as determined by CT, MRI or positron emission tomography (PET) scan * Hemoglobin \> 9 g/dL (prior to leukapheresis) * Absolute n…

What they're measuring

Incidence of adverse events

Timeframe: Up to 12 months after last chimeric antigen receptor (CAR) T cell infusion

Dose-limiting toxicity rates

Timeframe: Within 28 days of last CAR T cell infusion

Trial details

NCT IDNCT06094842

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-15