Phase 1 Dose Escalation And Expansion Study Of Intralesional TROP2-CAR/ IL15 TGFBR2 KO Engineered Cord Blood-Derived NK Cells In Patients With Diffused Or Multifocal Oral Premalignant Lesions
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTROP2 CAR/IL-15 TGFBR2 KO NK cells
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.
Location
- MD Anderson Cancer CenterHouston, Texas