US-based biotechnology company Adicet Bio has dosed the first subject in a multicentre Phase I trial of ADI-270, a gamma delta CAR T-cell therapy for treating metastatic or advanced clear-cell renal cell carcinoma (ccRCC).
The open-label trial will evaluate the therapy as a single agent in adult subjects who have experienced a relapse or have refractory metastatic/advanced ccRCC.
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Subjects will receive an initial dose of 3E8 CAR+ cells after a lymphodepletion regimen. They can later receive a second dose of the therapy if certain criteria are met.
The trial will progress through dose escalation and expansion stages to assess ADI-270’s tolerability, pharmacokinetics and safety.
The drug’s anti-tumour activity will be measured by the duration of response, disease control rate and overall response rate.
Adicet Bio president and CEO Chen Schor said: “Dosing the first patient in our Phase I trial of ADI-270 in metastatic/advanced ccRCC is a significant milestone for Adicet as we advance our first gamma delta 1 CAR T-cell product candidate for the treatment of solid tumours, one of the highest unmet needs in oncology.
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By GlobalData“Based on ADI-270’s encouraging preclinical data generated to date, in which ADI-270 demonstrated significant tumour infiltration, resistance to the immunosuppressive tumour microenvironment and potent activity via CAR and innate-mediated targeting, we believe ADI-270 has the potential to offer a promising advancement for solid tumours.”
Engineered to target CD70-positive cancers, ADI-270 uses a third-generation CAR, leveraging CD27 as the binding component.
The drug includes a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII) to enhance its function within the immunosuppressive tumour microenvironment.
It is designed to improve treatment durability and reduce the host versus graft reaction risks.
Adicet Bio expects to report preliminary clinical data from the trial in the first half of next year.
Earlier this year, the US Food and Drug Administration (FDA) approved an investigational new drug application for ADI-270.
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