Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)
M.D. Anderson Cancer Center
Summary
To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.
Description
Primary Objective: To determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) combined with and without preconditioning RT in patients with advanced head and neck squamous cell carcinoma. Secondary Objectives: 1. To determine the antitumor activity of TROP2 CAR/IL-15 TGFBR2 KO NK cells, including those with pre-CAR-NK bridging SBRT in patients eligible to receive this. Although the clinical benefit of TG TROP2…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy. Patient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories. * 2 weeks from the last cytotoxic chemotherapy at the time of lympho…
Interventions
- DrugFludarabine
Given by infusion
- DrugCyclophosphamide
Given by infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas