FDA greenlights phase 1 trial of ADI-212 in mCRPC

The FDA has granted clearance to an investigational new drug (IND) application for ADI-212, allowing Adicet Bio to proceed with a phase 1 trial (NCT07793435) of the agent in metastatic castration-resistant prostate cancer (mCRPC).¹

ADI-212 is a next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). Patient enrollment in the phase 1 study is expected to begin in the fourth quarter of 2026.

“ADI-212 marks an important milestone in Adicet’s strategy to address the complexity of solid tumors and represents an important addition to our portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs,” said Blake Aftab, PhD, Chief Scientific Officer of Adicet Bio, in the company’s news release.¹ “Designed as a single off-the-shelf product, ADI-212 incorporates multiple platform enhancements by combining gene-editing and the expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing, and active modulation of tumor microenvironment. The successful IND clearance reinforces our commitment to advancing innovative therapies for patients with cancer.”

About the study

The phase 1/2, open-label, multicenter study plans to enroll approximately 12 adult patients with mCRPC.² To be eligible for enrollment, participants must have progressive disease following prior therapy, an ECOG performance status of 0 or 1, and castration testosterone levels below 50 ng/dL, and patients must remain on androgen deprivation therapy to maintain this level.

Patients are not eligible for enrollment if they have had prior radiation therapy within 21 days of study treatment initiation, prior positive superscan results, or prior treatment with CAR-T therapy.

The study will be conducted in a dose escalation and dose expansion design. In the first phase of the study, ADI-212 will be administered across 3 planned dose levels to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D) for expansion. Phase 2 will assess preliminary anti-tumor responses to ADI-212 at the RP2D level. The primary end points are the incidence of dose-limiting toxicities and the proportion of patients with treatment-related adverse events.

Primary completion of the trial is expected in October 2028. 

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