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

Phase 1 Terminated 52 enrolled Regeneron Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-11-30
Primary completion: 2023-03-14
Completion: 2023-03-14

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “Due to a Dose Limiting Toxicity.”

paper after which the study was terminated, without determination of the RP2D. PMID 39737899 ↗

Publications

Stein MN, Dumbrava EE, Teply BA, Gergis US, Guiterrez ME, Reshef R, Subudhi SK, Jacquemont CF, Senesac JH, Bayle JH, Scripture CD, Chatwal MS, Bilen MA, Stadler WM, Becerra CR. PSCA-targeted BPX-601 CAR T cells with pharmacological activation by rimiducid in metastatic pancreatic and prostate cancer: a phase 1 dose escalation trial. Nat Commun. 2024 Dec 30;15(1):10743. doi: 10.1038/s41467-024-53220-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BPX-601	Cell therapy	—	Intravenous
Subject	Rimiducid	Other / unclassified	—	Intravenous