NCT05922930

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood and peritoneal cavity in the recipient. 4. To profile and assess the dynamic changes in the peritoneal tumor microenvironment before and after treatment using single-cell transcriptional and immune profiling on peritoneal cells at various time points before and after treatment. 5. To estimate patient reported symptom burden and quality of life longitudinally through treatment and follow up. 6. To compare changes in circulating tumor DNA (ctDNA) with response as determined by RECIST v1.1 Endpoints: 1. Objective response rates at week 12 2. Median progression free survival 3. TROP2-CAR NK cell numbers in peripheral blood and peritoneal cavity vs time profile 4. Characterization of lymphocyte populations at various time points 5. PROMIS-19, EQ-5D-5L, and MDASI-OC PRO questionnaire responses 6. Plasma ctDNA concentration at baselines and serial timepoint

Conditions

• Pancreatic Cancer
• Ovarian Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	TROP2-CAR-NK	Given by IP (intraperitoneal)
DRUG	Cyclophosphamide	Given by IV (vein)
DRUG	Fludarabine	Given by IV (vein)

Timeline

• Start date: 2023-10-11
• Primary completion: 2027-10-15
• Completion: 2028-01-15
• First posted: 2023-06-28
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study