RecruitingPhase 1NCT06623396

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

18 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of treatment called CAR T-cell therapy — where a patient's own immune cells are genetically modified to attack cancer — targeting a protein called mesothelin found on certain tumor cells. This is for people with advanced stomach or gastroesophageal junction (GEJ) cancer that has spread. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic esophagogastric adenocarcinoma (stomach or GEJ cancer) confirmed by pathology - Your cancer has spread or come back after prior treatment - Your physical health is reasonable (ECOG 0–1) - Your life expectancy is at least 4 months - More than 25% of your tumor cells express the mesothelin protein (confirmed by testing) - You have stage IV disease with spread to the abdominal lining (peritoneal carcinomatosis) **You may NOT be eligible if...** - You have not had pathology confirming mesothelin expression - Your general health or organ function is too poor to undergo the procedure - You have significant active infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALM28z1XXPD1DNR 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.