Adicet Bio, Inc. has announced the enrollment of the first patient in its Phase 1 clinical trial evaluating ADI-270, a novel allogeneic gamma delta CAR T-cell therapy, for patients with metastatic or advanced clear cell renal cell carcinoma (ccRCC). This trial marks a significant step forward in the development of cell-based immunotherapies for solid tumors, an area of high unmet medical need.
The Phase 1 trial is a multicenter, open-label study designed to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ADI-270 as a monotherapy in adult patients with relapsed or refractory ccRCC. Following lymphodepletion, patients will receive a single dose of ADI-270, starting at a dose level of 3E8 CAR+ cells. A second dose may be administered based on protocol-defined criteria. The trial will evaluate key endpoints such as overall response rate, duration of response, and disease control rate.
ADI-270: Targeting CD70 in Solid Tumors
ADI-270 is an "off-the-shelf" gamma delta CAR T-cell therapy candidate engineered to target CD70-positive cancers. CD70 is highly expressed in both solid and hematological malignancies, making it an attractive therapeutic target. ADI-270 is designed with a third-generation CAR that utilizes CD27, the natural receptor for CD70, as the binding moiety. Furthermore, it is armored with a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII) to enhance its functional resilience within the immunosuppressive tumor microenvironment. The therapy is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination.
Chen Schor, President and Chief Executive Officer at Adicet Bio, stated, "Dosing the first patient in our Phase 1 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 tumors, one of the highest unmet needs in oncology."
The Need for New Therapies in Advanced ccRCC
Renal cell carcinoma (RCC) is the most common type of kidney cancer, with clear cell RCC (ccRCC) being the most prevalent subtype, accounting for approximately 80% of all RCC cases. While the 5-year survival rate for localized RCC is 93%, it drops dramatically to 15% for patients with advanced disease. Approximately 20% of newly diagnosed RCC cases are already locally advanced or metastatic, and up to 30% of patients will develop metastatic disease after nephrectomy. Current therapies offer limited benefits for patients with advanced ccRCC, highlighting the urgent need for more effective treatments.
Anticipated Clinical Data
Adicet Bio anticipates sharing preliminary clinical data from the Phase 1 trial in the first half of 2025. These early results will provide valuable insights into the safety, tolerability, and potential efficacy of ADI-270 in patients with advanced ccRCC.
