A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer
Recruiting now · Phase 1
Conditions studied: Mesothelin Positive, Mesothelin-Expressing Tumors, Esophageal Adenocarcinoma, Esophageal Adenocarcinomas, Esophagogastric Adenocarcinoma, Peritoneal Carcinomatosis, Breast Neoplasms, Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT06623396
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 18
- Starts
- 2024-09-30
- Expected to finish
- 2028-09-30
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged ≥18 years
- Diagnosis of pathologically confirmed EG adenocarcinoma
- Diagnosis of metastatic or recurrent disease
- ECOG performance status of 0-1
- Life expectancy of ≥4 months
- Inclusion Criteria for Leukapheresis:
- Written informed consent for the study (from participant)
- Life expectancy of ≥4 months
- ECOG performance status of 0-1
- Histologic diagnosis that \& >25% of the tumor expresses MSLN by IHC analysis. Archival tissue obtained up to 2 years before study enrollment is acceptable. IHC testing of a cell block from cytology (e.g., ascitic fluid) is acceptable if approved by the study pathologist. If adequate archival tissue is not available at screening, a fresh tumor biopsy should be obtained
- Stage IV disease with gross peritoneal carcinomatosis on imaging and/or microscopic peritoneal involvement by cytology or noted during diagnostic laparoscopy
- Disease progression or treatment intolerance after receiving at least 1 treatment regimen in the metastatic setting; patients with disease recurrence within 6 months of completing curative systemic therapy (chemotherapy, chemoradiation or adjuvant immunotherapy) are also eligible
- Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy
- At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 6 weeks of signing the informed consent form
- Completion of systemic therapy at least 7 days before leukapheresis
- o Immune checkpoint inhibitor therapy must be completed at least 14 days before leukapheresis
- Lab requirements (hematology):
- Absolute neutrophil count ≥1.0 K/mcL
- Hemoglobin ≥9 gm/dL
- Platelet count ≥75 K/mcL
- Blood product transfusion or growth factor support cannot occur within 7 days of testing
- Lab requirements (serum chemistry):
- Bilirubin ≤1.5× upper limit of normal (ULN)
- Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) level ≤3× ULN
- Calculated clearance of ≥50 mL/min by Cockcroft-Gault equation
Where it is running
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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