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

Stopped early · Phase 1

Conditions studied: Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer

In brief

The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.

Key facts

Study ID

NCT02744287

Run by

Regeneron Pharmaceuticals

People needed

52

Starts

2016-11-30

Expected to finish

2023-03-14

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Nebraska — Omaha, Nebraska, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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