Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06623396

A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-11

18

Participants Needed

7

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Pathologically confirmed esophagogastric adenocarcinoma
  • Metastatic or recurrent disease
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 4 months
  • Written informed consent for study participation
  • Tumor with at least 25% mesothelin expression by immunohistochemistry
  • Stage IV disease with gross peritoneal carcinomatosis or microscopic peritoneal involvement
  • Disease progression or intolerance after at least one prior metastatic treatment
  • Patients with HER2-positive disease must have received at least one line of anti-HER2 therapy
  • At least one measurable or evaluable lesion per RECIST 1.1
  • Completion of systemic therapy at least 7 days before leukapheresis
  • Hematology lab values within specified limits (neutrophils ≥1.0 K/mcL, hemoglobin ≥9 gm/dL, platelets ≥75 K/mcL)
  • Serum chemistry lab values within specified limits (bilirubin ≤1.5x ULN, ALT/AST ≤3x ULN, clearance ≥50 mL/min)
  • Negative infectious disease screening
  • Negative serum pregnancy test for females of childbearing potential and agreement to use contraception for 12 months after infusion
  • Resolution of acute toxic effects from prior treatments to grade 1 or less (except neuropathy and alopecia)
Not Eligible

You will not qualify if you...

  • Pregnant or lactating
  • Active HIV, hepatitis B or C infection
  • Receiving treatment for another active malignancy (except treated in situ skin cancers)
  • Hematologic malignancy requiring treatment in past 5 years or history of lymphoid malignancy
  • Prior CAR T-cell or mesothelin-directed therapy
  • Major abdominal surgery completed less than 28 days before enrollment
  • Untreated or active central nervous system metastases
  • Active autoimmune disease requiring systemic treatment within past year
  • Receiving high-dose systemic corticosteroids or immunosuppressive therapy
  • Severe cardiac conditions including advanced heart failure or recent myocardial infarction
  • Active interstitial lung disease or pneumonitis requiring steroids
  • Oxygen saturation below 90% on room air
  • Active infection requiring antibiotics within 7 days before leukapheresis
  • Any other medical condition interfering with study participation
  • Receipt of live attenuated vaccine within 8 weeks before lymphodepleting chemotherapy
  • Deemed noncompliant with study requirements by the research team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

G

Geoffrey Ku, MD

CONTACT

P

Parastoo Dahi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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