About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Diagnosis of pathologically confirmed EG adenocarcinoma
Diagnosis of metastatic or recurrent disease
ECOG performance status of 0-1
Disqualifiers
Pregnant or lactating
HIV, active hepatitis C virus, or active hepatitis B virus infection, as determined by quantitative PCR (patients who have undergone negative testing prior to leukapheresis do not require repeat testing)
Receiving therapy for concurrent active malignancy
Note: Patients receiving treatment for in situ skin malignancies are not excluded.
Trial design
Single group
Treatments tested in this trial
M28z1XXPD1DNR CAR
Biological/VaccineParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of treatment-emergent adverse events
The primary objective of this study is to assess the safety of M28z1XXPD1DNR CAR T cells administered through the peritoneal cavity. CTCAE v5.0 will be used to assess the severity of all treatment-emergent toxicities and adverse events, regardless of reporting requirements
Maximum Tolerated Dose of M28z1XXPD1DNR CAR T cells
Determine the maximum tolerated dose of M28z1XXPD1DNR CAR T cells administered through the peritoneal cavity.
Sponsors and contacts
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