The US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application from Adicet Bio, allowing the company to begin a Phase I clinical trial of ADI-270 for relapsed or refractory renal cell carcinoma (r/r RCC).
ADI-270 is an armoured allogeneic ‘off-the-shelf’ gamma delta chimeric antigen receptor (CAR) T-cell therapy candidate that is designed to treat CD70+ cancers.
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The prospective, multicentre, open-label trial is set to begin in the second half of this year to evaluate the drug’s safety and anti-tumour activity in adults with clear cell r/r RCC.
Following lymphodepletion, participants will be given a single dose of ADI-270 with 3E8 CAR-positive cells, with the potential for a second dose based on specific criteria outlined in the study protocol.
The trial will have dose escalation and expansion phases to assess the therapy’s safety, tolerability and pharmacokinetics.
It will also measure anti-tumour activity using metrics such as overall response rate, duration of response and disease control rate.
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By GlobalDataAdicet Bio president and CEO Chen Schor said: “ADI-270 is the first ever gamma delta 1 CAR T-cell therapy candidate to enter clinical trials for the treatment of solid tumours.
“The FDA’s clearance of our IND application to evaluate ADI-270 in patients with RCC underscores a significant achievement for Adicet.
“ADI-270 is a third-generation CAR T designed to target CD70+ tumours with high specificity, increased exposure, persistence and tumour infiltration, while addressing immunosuppressive factors in the tumour microenvironment.
“With its highly differentiated profile, we believe that ADI-270 has the potential to become an important therapeutic option for patients with RCC and other CD70+ tumours.”
Based in Massachusetts, Adicet Bio works to discover and develop allogeneic gamma delta T-cell therapies for autoimmune diseases and cancer.
Last year, the company decided to focus on advancing ADI-270 and ADI-001, another CAR-T cell therapy, after pausing its preclinical programme for ADI-925.
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