Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)
M.D. Anderson Cancer Center
Summary
To find the recommended dose of TROP2- CAR-NK cells that can be given to participants with advanced forms of solid tumors.
Description
Primary Objective: 1\. To determine the safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of TROP2-CAR-NK cells in participants with solid tumors with high TROP2 expression. Secondary Objectives: 1. To determine the antitumor activity of TROP2-CAR-NK cells in participants with high TROP2-expressing NSCLC and high TROP2-expressing HER2-negative/low breast cancer. Although the clinical benefit of TROP2-CAR-NK cells has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet the following criteria for study entry: 1. Participants must be 18 years or older. 2. Participants must be willing and able to provide informed consent. 3. In the dose escalation, participants must have histologically documented locally advanced, unresectable, or metastatic solid tumor that has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available, or refused such therapy. 4. In dose expansion Cohort 1, patients must have histologically documented locally advanced,…
Interventions
- DrugRimiducid
Given by (IV) vein
- DrugTROP2-CAR-NK Cells
Given by (IV) vein
- DrugFludarabine phosphate
Given by (IV) vein
- DrugCyclophosphamide
Given by (IV) vein
Location
- M D Anderson Cancer CenterHouston, Texas