December 17, 2020 -- Kiromic BioPharma has submitted two investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA) for its programmed cell death 1 (PD-1) gamma-delta chimeric antigen receptor T cell (CAR T) therapy.
The INDs are for a phase I clinical trial of intravenously delivered allogenic CAR T cells for epithelial ovarian carcinoma and malignant pleural mesothelioma, as well as for another phase 1 trial for an intrapleural/intraperitoneal-delivered allogenic CAR T cells for epithelial ovarian carcinoma and malignant pleural mesothelioma. The cells are manufactured using the company's proprietary gamma-delta T-cell platform.
The trials are expected to enroll 12 patients over four months at two sites, and the first human dose is expected to be administered in the first quarter of 2021, the company said.
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