Actively Recruiting
PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer
Led by City of Hope Medical Center · Updated on 2025-11-19
21
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if applicable
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or approval for exceptions
- Age 18 years or older
- ECOG performance status 0-2 or Karnofsky Performance Status 70% or higher
- Documented metastatic castration-resistant prostate cancer with PSCA+ tumor expression confirmed
- Disease progression despite advanced androgen targeted therapy
- For radiation group, presence of 1 to 3 metastases suitable for radiation
- Fully recovered from prior anti-cancer therapy acute toxic effects to grade 1 or less (except alopecia)
- At least 2 weeks since prior chemotherapy before leukapheresis
- Prior radiotherapy allowed if not the only evaluable disease site and completed over 14 days before leukapheresis
- No contraindications to leukapheresis, steroids, or tocilizumab
- Absolute neutrophil count 1000/mm3 or higher within 42 days before enrollment
- Platelet count 100,000/mm3 or higher within 42 days before enrollment
- Total serum bilirubin 2.0 mg/dL or less (or up to 3.0 x ULN if Gilbert syndrome) within 42 days before enrollment
- AST and ALT 2.5 x ULN or less within 42 days before enrollment
- Creatinine clearance 50 mL/min or higher within 42 days before enrollment
- Corrected QT interval 480 ms or less within 28 days before therapy
- Cardiac function without acute abnormalities within 42 days before enrollment
- Negative for active HIV, hepatitis B/C, syphilis or undetectable viral load if positive
- Agree to effective birth control or abstinence during study and 3 months after last dose if of childbearing potential
You will not qualify if you...
- Current use of systemic steroids or chronic immunosuppressants (inhaled steroids allowed)
- Clinically significant or unstable arrhythmias within 2 weeks before screening
- History of optic neuritis or other CNS inflammatory diseases including seizures
- History of allergic reactions to similar compounds as study agent
- Known bleeding disorders like von Willebrand's disease or hemophilia
- Stroke or brain hemorrhage within 6 months before screening
- History of other malignancies except certain treated cancers with no active disease for 3 or more years
- Clinically significant uncontrolled illnesses
- Active infections requiring antibiotics
- Known HIV, hepatitis B or C infections
- Any condition that in the investigator's judgment contraindicates study participation
- Inability to comply with all study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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