Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

Inclusion Criteria:

Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
Age ≥18 years.
Life expectancy > 12 weeks.
ECOG 0-1
Adequate organ function.

Exclusion Criteria:

Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
Symptomatic, untreated, or actively progressing central nervous system metastases.
Impaired cardiac function or clinically significant cardiac disease.
Pregnant or breastfeeding.
Participant requires chronic, systemic steroid therapy.
Severe intercurrent infection.
Known HIV positivity.