RecruitingPhase 1NCT05805371

PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer

A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer


Sponsor

City of Hope Medical Center

Enrollment

21 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production. 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 (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. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving PSCA-targeting CAR T-cells, with or without radiation, may kill more tumor cells in men with castration-resistant prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing PSCA-targeting CAR T-cell therapy — either alone or combined with targeted radiation — for men with advanced, treatment-resistant prostate cancer that expresses a protein called PSCA. CAR T-cell therapy reprograms your own immune cells to attack cancer cells. **You may be eligible if:** - You are 18 or older - You have confirmed castration-resistant prostate cancer that has spread (mCRPC) — meaning the cancer keeps growing even when testosterone is suppressed to very low levels - Your tumor tests positive for PSCA expression (confirmed by a lab test on a biopsy sample) - You are in good general health (ECOG 0–2 or Karnofsky score 70 or above) **You may NOT be eligible if:** - Your cancer does not express PSCA - You have not had standard hormonal therapy - Your general health is too poor to safely receive the treatment - You have other serious active illnesses that may interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes

Given IV

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood, stool, and urine sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT scan

RADIATIONExternal Beam Radiation Therapy

Undergo radiation

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDURELymphodepletion Therapy

Undergo lymphodepletion


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05805371


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