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Despite fundamentally altering treatment options for hematologic cancers, the application of CAR T-cell therapy to solid tumours has proven difficult due to challenges such as the limited persistence of CAR T cells, difficulty reaching and penetrating tumour masses, and the risk of targeting healthy cells that also express low levels of tumour-associated proteins. To address this, John Haanen, MD, PhD, of the Netherlands Cancer Institute and colleagues conducted a first-in-human, open-label, multicenter clinical trial evaluating a CAR T-cell product targeting CLDN6, a tumour-specific antigen widely expressed in solid tumours but silenced in healthy adult tissues. The treatment was evaluated both as a monotherapy and in combination with CARVac, a CLDN6-encoding mRNA vaccine designed to promote the growth and persistence of CAR T cells in the blood, with the combined approach known as BNT211 demonstrating an enhanced capacity to multiply transferred CAR T cells and improve tumour cell killing.
In the phase I/II trial presented at the AACR Annual Meeting 2022, a total of 16 patients with relapsed or refractory advanced CLDN6-positive solid tumours were treated, with the trial divided into two parts covering monotherapy and combination therapy with CARVac administered every two to three weeks for the first 100 days. Approximately 40 percent of patients developed manageable cytokine release syndrome with no evidence of neurotoxicity, and other adverse events such as cytopenia resolved on their own, leading Haanen to characterize the treatment as safe with only a limited number of easily manageable adverse events. An overall response rate of nearly 43 percent was observed, with four testicular cancer patients and two ovarian cancer patients achieving partial responses at six weeks, and at 12 weeks all evaluable patients showed improvement in their initial responses, including one ongoing complete remission still present six months after infusion. Haanen noted that CLDN6 had never previously been targeted with cellular therapy, and emphasized that while the data are very early and conclusions remain preliminary, the results already show efficacy that may compare favourably to other CAR T trials in solid tumours
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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