M.D. Anderson Cancer Center
This is a Phase I/II study evaluating the intraperitoneal delivery of TROP2 CAR/IL-15 TGFBR2 KO NK cells in combination with oral belzutifan (120 mg daily) for patients with recurrent, locally advanced, unresectable and metastatic pancreatic cancer. The primary objectives are to assess safety and determine the recommended Phase II dose (RP2D).
Primary Objective: To determine the safety of TROP2 CAR/IL-15 TGFBR2 KO NK cell administered intraperitoneally and intravenously in combination with belzutifan at the flat dose of 120 mg orally daily and define the MTD/RP2D of CAR-NK cells. Primary Endpoints: Adverse events as scored by CTCAE V5.0 Dose-limiting toxicity as defined in Section 5.4 Secondary Objectives: To estimate the best objective response rate (ORR) in patients at 12 weeks after infusion. To estimate progression-free survival and overall survival. To quantify the persistence of infused allogeneic donor CAR-transduced CB…
Inclusion Criteria: 1. Subjects must be 18 years or older. 2. Subjects must be willing and able to provide informed consent. 3. Subjects with a histologically confirmed diagnosis of pancreatic ductal adenocarcinoma or ampullary-type carcinoma 4. Subjects who have progressive disease after receiving initial treatment with either FOLFIRINOX, or a gemcitabine-based therapy 5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. A female participant is eligible to participate if at least one of the following conditions applies: * Not a woman of chil…
Given by mouth
Arctuva estimate
Verify or correct the compensation shown for this listing.