NCT06623396

A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer

A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks.

Conditions

• Mesothelin Positive
• Mesothelin-Expressing Tumors
• Esophageal Adenocarcinoma
• Esophageal Adenocarcinomas
• Esophagogastric Adenocarcinoma
• Peritoneal Carcinomatosis
• Breast Neoplasms
• Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	M28z1XXPD1DNR CAR	Participants with esophagastric adenocarcinoma will be treated with an intraperitoneal infusion of different doses of autologous T cells that have been genetically modified ex vivo to express the M28z1XXPD1DNR CAR. The CAR T cells will be manufactured in MSK's Center for Cell Engineering.

Timeline

• Start date: 2024-09-30
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2024-10-02
• Last updated: 2026-02-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study