OncoMatch/Clinical Trials/NCT06623396
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Official title: A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis or Malignant Peritoneal Mesothelioma
Is NCT06623396 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Ovarian Cancer
Breast Carcinoma
Biomarker criteria
Required: MSLN expression (≥25% of tumor expresses MSLN by IHC)
Histologic diagnosis that & >25% of the tumor expresses MSLN by IHC analysis
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic setting
Disease progression or treatment intolerance after receiving at least 1 treatment regimen in the metastatic setting
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 ≥1.0–1.5 K/mcL; Hemoglobin ≥8–9 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
Left ventricular ejection fraction >40%; no NYHA stage III/IV CHF; no MI ≤6 months; no history of myocarditis; no serious uncontrolled arrhythmia, unstable angina, or uncontrolled infection
Lab requirements (hematology): Absolute neutrophil count ≥1.0–1.5 K/mcL; Hemoglobin ≥8–9 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/IV CHF, MI ≤6 months, history of myocarditis, serious uncontrolled arrhythmia, unstable angina, or uncontrolled infection, 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 →Frequently asked questions
Is NCT06623396 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, mesothelin-directed therapy disqualifies patients from enrollment.
Does this trial require MSLN?
Yes, MSLN expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages