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
Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma
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
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, enzalutamide, apalutamide, or darolutamide)
Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone <50 ng/dL AND agrees to stay on LHRH agonist or antagonist therapy during the study
Structurally unstable bone lesions suggesting impending fracture
Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively treated. Participants with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis or prophylactic dose of oral anticoagulant and asymptomatic within 4 weeks of the planned BPX-601 infusion
Inadequate renal function defined by creatinine clearance <60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula
Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >2.5 × ULN or >5 × ULN, if liver metastases, and/or total bilirubin >1.5 × ULN, as described in the protocol
Single group
BPX-601
GeneticAdministered per protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Occurrence of Dose Limiting Toxicities (DLTs)
Occurrence of Adverse Events of Special Interest (AESIs)
Objective response
Duration of Response (DoR)
Disease control
≥50% reduction in Prostate-Specific Antigen (PSA50) response
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