Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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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