M.D. Anderson Cancer Center
This is a phase 1, single-arm, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of TGFBR2 TROP2 CAR/IL15 NK cells in patients with high-risk oral premalignant lesions.
Primary Objective: • To characterize the safety and tolerability of TROP2 CAR/IL15 TGFBR KO NK cells in patients with high-risk oral premalignant lesions. Secondary Objectives: * To determine the antitumor activity of TROP2 CAR/IL15 TGFBR KO NK cells. * To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in recipient. * To conduct comprehensive immune correlative studies by evaluating tissue and bloodbased biomarkers associated with response and resistance to TROP2 CAR/IL-15 TGFBR2 KO NK cell injection in part using longitudinal paired biopsies obtaine…
Inclusion Criteria: 1. Subjects with diffuse or multifocal oral premalignant lesions are eligible for this study and must have a confirmed histologic diagnosis of oral epithelial dysplasia or oral intraepithelial neoplasia. Diffuse disease is defined as a single lesion measuring 2 cm in greatest dimension, and multifocal disease is defined as the presence of two or more spatially distinct premalignant lesions within the oral cavity. Patients with a history of histologically confirmed head and neck squamous cell carcinoma, including oral cavity squamous cell carcinoma, are eligible provided th…
Participants will receive one of two doses of TROP2 CAR/IL-15 TGFBR2 KO NK injection on D0 and every three weeks thereafter, receive up to a total of 4 cycles at either dose.
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