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ADI-212 Receives FDA IND Clearance for Castration-Resistant Prostate Cancer
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Fusion42 · 28 August 2026 · Fusion42 review
The FDA has cleared the IND application for ADI-212, an off-the-shelf gene-edited allogeneic gamma delta 1 CAR T cell therapy targeting PSMA in metastatic castration-resistant prostate cancer, with a phase 1 trial planned for Q4 2026.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
◆ ◆ The Wire takeaway
Your clinical-stage biotech now faces an opening in solid tumour CAR T therapy where patient-specific manufacturing bottlenecks are easing. This FDA clearance shifts patient access potential by favouring off-the-shelf, gene-edited products targeting prostate cancer.
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2 sources · 28 Aug 2026
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