OncoMatch/Clinical Trials/NCT06623396
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer
Is NCT06623396 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies M28z1XXPD1DNR CAR for mesothelin positive.
Treatment: M28z1XXPD1DNR CAR — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Ovarian Cancer
Breast Carcinoma
Biomarker criteria
Required: MSLN overexpression (>25% of the tumor expresses MSLN by IHC analysis)
Histologic diagnosis that & >25% of the tumor expresses MSLN by IHC analysis
Allowed: HER2 (ERBB2) overexpression
Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
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
Must have received: HER2-targeted therapy
Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy
Cannot have received: CAR-T cell therapy
Previous receipt of CAR T cell therapy or any other cellular therapy
Cannot have received: mesothelin-directed therapy
Previous mesothelin-directed therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 or 1.5 K/mcL (depending on phase); Hemoglobin ≥8 or 9 gm/dL; Platelet count ≥75 K/mcL; Blood product transfusion or growth factor support cannot occur within 7 days of testing
Kidney function
Calculated clearance of ≥50 mL/min by Cockcroft-Gault equation
Liver function
Bilirubin ≤1.5× ULN; ALT/AST ≤3× ULN
Cardiac function
No NYHA stage III or IV CHF, MI ≤6 months, history of myocarditis, serious uncontrolled arrhythmia, unstable angina, LVEF ≤40%
Lab requirements (hematology): Absolute neutrophil count ≥1.0 or 1.5 K/mcL; Hemoglobin ≥8 or 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× ULN; ALT/AST ≤3× ULN; Calculated clearance of ≥50 mL/min by Cockcroft-Gault equation. Cardiac: NYHA stage III or IV CHF, MI ≤6 months, history of myocarditis, serious uncontrolled arrhythmia, unstable angina, LVEF ≤40% [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited protocol activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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