OncoMatch/Clinical Trials/NCT06623396
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer
Is NCT06623396 recruiting? Yes, currently enrolling (Jun 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 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 →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 overexpression 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