Adicet Bio (Nasdaq: ACET) reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for ADI-212, an allogeneic gamma delta 1 CAR T cell therapy candidate for patients with metastatic castration-resistant prostate cancer (mCRPC). Phase 1 enrollment in mCRPC is expected to begin in the fourth quarter of 2026.According to Adicet Bio, ADI-212 is a next-generation, gene-edited, off-the-shelf cell therapy targeting PSMA, engineered with membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of MED12 to support tumor-specific recognition and multiple anti-tumor mechanisms in the tumor microenvironment.

Adoptive cell therapies used to treat advanced prostate cancer are being developed to target several tumor-associated antigens, including prostate-specific membrane antigen (PSMA). Chimeric antigen receptor (CAR) T cell therapy using the single chain variable fragment (scFv) derived from the humanized murine mAb clone, J591, as the antigen-binding domain has shown promising anti-tumor activity. However, it has also been associated with macrophage activation syndrome and other unwanted toxicities, highlighting the need for more specific and human-derived antigen-binders with optimized construct designs for improved safety and efficacy.

Chimeric antigen receptor (CAR)-modified macrophages (CAR-Ms) are a promising approach for the treat

Chimeric antigen receptor (CAR)-modified macrophages (CAR-Ms) are a promising approach for the treat