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JNJ-80038114 is a bispecific T-cell engager (BiTE) designed to redirect T-cells to target prostate-specific membrane antigen (PSMA)-expressing tumor cells. It binds both CD3 on T-cells and PSMA on prostate cancer cells, stimulating T-cell activation and cytotoxicity against the tumor. The drug is being developed by Janssen Research & Development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). As of March 2025, it has completed Phase 1 clinical trials in patients with advanced stage or metastatic castration-resistant prostate cancer[1][3][5][6]. The agent is not yet approved for use in any country[7].
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