REDWOOD CITY, Calif. – August 27, 2026
Adicet Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ADI-212, a next-generation gene-edited allogeneic gamma delta 1 cell therapy candidate being developed for patients with metastatic castration-resistant prostate cancer (mCRPC). Following the regulatory clearance, Adicet Bio plans to begin Phase 1 enrollment in the fourth quarter of 2026, marking an important clinical development milestone for the company’s solid-tumor cell therapy strategy. ADI-212 is designed as an off-the-shelf cell therapy, potentially allowing treatment to be manufactured in advance rather than relying on individualized manufacturing for every patient. The program expands Adicet Bio’s clinical development efforts in solid tumors while leveraging its broader expertise in engineered allogeneic gamma delta T-cell therapies..
ADI-212 Uses Multiple Engineering Approaches
ADI-212 is engineered to target prostate-specific membrane antigen (PSMA), a clinically established target in prostate cancer, using a novel chimeric antigen receptor (CAR) binder intended to support tumor-specific recognition and tolerability. The candidate incorporates several engineering features intended to enhance activity against solid tumors, where the tumor microenvironment can create significant barriers for conventional cellular immunotherapies. Adicet Bio has combined gene editing, CAR targeting and immune-stimulating armoring within the single investigational product. The company said the therapy is designed to provide multiple mechanisms of anti-tumor activity, including enhanced antigen engagement and potentially more durable tumor-cell killing. These characteristics are intended to support the development of a scalable cellular therapy approach for patients with advanced prostate cancer.
Gene Editing Designed to Strengthen Tumor Activity
A central feature of ADI-212 is its combination of membrane-tethered IL-12 armoring with CRISPR/Cas9-mediated disruption of MED12, a subunit of the mediator complex. According to Adicet Bio, these modifications are intended to improve the activity of the engineered cells within the challenging environment of solid tumors. The IL-12 armoring approach is designed to provide localized immune stimulation, while MED12 disruption is intended to contribute to enhanced cellular potency. The program therefore represents a multi-component engineering strategy rather than a conventional CAR T-cell design. By combining these modifications with PSMA-directed targeting, Adicet Bio aims to create a cell therapy capable of recognizing prostate cancer cells while maintaining activity within the tumor microenvironment.
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Phase 1 Development Expected in Q4 2026
The FDA IND clearance enables Adicet Bio to move ADI-212 into clinical development, with Phase 1 enrollment in patients with mCRPC expected to begin during the fourth quarter of 2026. The upcoming study will provide the first clinical opportunity to evaluate the candidate’s safety and initial clinical characteristics in patients with advanced prostate cancer. The program also represents an important test of Adicet Bio’s broader strategy of developing allogeneic gamma delta T-cell therapies for solid tumors. The company is advancing ADI-212 alongside other engineered cellular therapy programs, seeking to overcome limitations that have historically affected cell therapy development in solid tumors. With FDA clearance now secured, the next major development focus will be clinical execution and generation of early human data for this gene-edited, PSMA-targeted candidate.
Source: Adicet Bio,press relese
