A Phase 1, Open-Label, Dose-Escalation Study of BPX-601, an Anti-PSCA CAR T Cell Drug Product, in Relapsed/Refractory Metastatic Castration-Resistant Prostate Cancer
Regeneron Pharmaceuticals
Summary
This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies. The study is looking at: * What side effects BPX-601 might cause * What is the best dose of BPX-601 * How well BPX-601 may work to destroy prostate cancer
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma 2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, as defined in the protocol 3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting \[in addition to Androgen Deprivation Therapy (ADT)\] including at least 1 second-generation anti-androgen therapy (eg, abiraterone, enzalutam…
Interventions
- GeneticBPX-601
Administered per protocol
Location
- John Theurer Cancer CenterHackensack, New Jersey