Phase I/II Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer
M.D. Anderson Cancer Center
Summary
To find the recommended dose of TROP2- CAR-NK given intraperitoneally (directly into the abdominal cavity) to patients with highgrade serous ovarian cancer that has not responded to previous treatment or is resistant to treatment.
Description
Primary Objectives: 1\. To determine the safety and optimal cell dose of TROP2-CAR/IL15-transduced CB-NK cells\[TROP2-CAR NK cells (KSR)\]delivered intraperitoneally and define the MTD/RP2D. Endpoints 1. Dose-limiting toxicity 2. MTD and RP2D of TROP2-CAR/IL15-transduced CB-NK cells and TROP2-CAR/IL15-transduced CB-NK cells \[TROP2-CAR NK cells (KSR)\] dose Secondary Objectives and Endpoints Objectives: 1. To estimate the best objective response rate (ORR) in patients at 12 weeks after infusion. 2. To estimate median progression free survival. 3. To quantify persistence of infused alloge…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Subjects must be 18 years or older. 2. Subjects must be willing and able to provide informed consent. 3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. A female participant is eligible to participate if at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 2. A WOCBP who agrees to follow the contraceptive guidelines in Appendix 1 during the treatment period and for at least 3 months after the last dose of study treatment. 5. Subjects must have m…
Interventions
- DrugTROP2-CAR-NK
Given by IP (intraperitoneal)
- DrugCyclophosphamide
Given by IV (vein)
- DrugFludarabine
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas