At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓ECOG performance status 0-2 or KPS ≥70%
- ✓Documented castration-resistant prostate cancer (mCRPC)
- ✓PSCA+ tumor expression confirmed by institutional pathology lab
- ✕Concurrent use of systemic steroids or chronic immunosuppressants (inhaled steroids and physiologic steroid replacement allowed)
- ✕Clinically significant arrhythmia not stable on medical management within 2 weeks of screening
- ✕History of optic neuritis or other immunologic/inflammatory CNS disease including seizure disorder
- ✕History of allergic reactions to compounds with similar chemical/biologic composition to study agent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer
In Brief
A Phase 1 clinical trial evaluating Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes, Biopsy, and 6 other interventions for Castration-Resistant Prostate Carcinoma and 2 related conditions. Currently recruiting, targeting 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given IV
Undergo tumor biopsy
Undergo blood, stool, and urine sample collection
Undergo bone scan
Undergo CT scan
Undergo radiation
Undergo leukapheresis
Undergo lymphodepletion