OncoMatch/Clinical Trials/NCT05805371
PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer
Is NCT05805371 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes for castration-resistant prostate carcinoma.
Treatment: Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSCA overexpression
Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)
Disease stage
Required: Stage IVB (AJCC v8)
Metastatic disease required
Stage IVB Prostate Cancer AJCC v8
Performance status
ECOG OR KARNOFSKY 0–2
Prior therapy
Must have received: advanced androgen targeted therapy (abiraterone, enzalutamide)
Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide)
Lab requirements
Blood counts
ANC >= 1,000/mm^3 (no growth factor within 14 days); Platelets >= 100,000/mm^3 (no platelet transfusion within 14 days)
Kidney function
Creatinine clearance of >= 50 mL/min per 24 hour urine test or Cockcroft-Gault formula
Liver function
Total serum bilirubin <= 2.0 mg/dL (Gilbert syndrome: <= 3.0 x ULN and direct bilirubin <= 1.5 x ULN); AST <= 2.5 x ULN; ALT <= 2.5 x ULN
Cardiac function
QTc <= 480 ms (within 28 days prior to day 1 of protocol therapy); Cardiac function (12-lead ECG) without acute abnormalities requiring investigation or intervention
ANC >= 1,000/mm^3 (within 42 days prior to enrollment); Platelets >= 100,000/mm^3 (within 42 days prior to enrollment); Total serum bilirubin <= 2.0 mg/dL (within 42 days prior to enrollment); AST <= 2.5 x ULN (within 42 days prior to enrollment); ALT <= 2.5 x ULN (within 42 days prior to enrollment); Creatinine clearance of >= 50 mL/min per 24 hour urine test or Cockcroft-Gault formula (within 42 days prior to enrollment); QTc <= 480 ms; Cardiac function (12 lead- electrocardiogram [ECG]) without acute abnormalities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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