NCT07509008

Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Management Of Gastric Cancer Metastatic To The Peritoneum

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to study the recommended dose of TROP2 CAR/IL-15 TGFBR2 KO NK cells that can be given intraperitoneally (infused directly into the stomach area) to participants with adenocarcinoma of the stomach that has spread to the peritoneum. The safety and effectiveness of this treatment will also be studied.

Detailed description

Primary Objectives: To determine the safety, MTD, and RP2D of TROP2 CAR/IL-15 TGFBR2 KO NK cells delivered intraperitoneally and define the MTD/RP2D. Endpoints 1. Dose-limiting toxicity 2. MTD and RP2D of TROP2 CAR/IL-15 TGFBR2 KO NK cells Secondary Objectives: 1. To estimate median overall survival. 2. To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood and peritoneal cavity in the recipient. 3. 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 before and after treatment. 4. To compare changes in circulating tumor DNA (ctDNA) with response as determined by the peritoneal carcinomatosis index Endpoints 1. Median overall survival 2. TROP2 CAR/IL-15 TGFBR2 KO NK cells numbers in peripheral blood and peritoneal cavity vs time profile 3. Characterization of lymphocyte populations before and after treatment 4. Plasma ctDNA concentration and peritoneal carcinomatosis index at baseline and after treatment Although the clinical benefit of this treatment has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response in addition to safety and tolerability

Conditions

• Gastric Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	TGFBR2 KO CAR27/IL-15 NK cells	Given by infusion
DRUG	Rimiducid (AP1903)	Given by IV
DRUG	Fludarabine	Given by IV
DRUG	Cyclophosphamide	Given by IV

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study