Actively Recruiting
A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-11
18
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called Mesothelin-targeted CAR T-cell therapy for people with mesothelin-positive esophagogastric adenocarcinoma who also have peritoneal carcinomatosis. This phase I trial aims to study the effects and safety of this therapy delivered directly into the abdomen. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with advanced cancer who have limited treatment options. Participants will have their white blood cells (T cells) collected through a procedure called leukapheresis. These cells will be modified in a lab to target mesothelin, a protein expressed on their tumors, creating the M28z1XXPD1DNR CAR T cells. The modified cells will then be infused back into the participant's abdomen. The therapy period will last about 3 to 4 weeks, during which different doses of the CAR T cells may be given to assess safety and dosage limits. Throughout the study, participants will undergo various assessments including imaging to evaluate tumor response, blood tests to monitor cell counts and chemistry, and tests for infectious diseases. Researchers will track treatment-related side effects for up to one year and determine the maximum tolerated dose of the CAR T cells. Participants must meet strict health criteria to ensure safety. The total participation time includes pre-treatment evaluations, treatment infusion, and follow-up monitoring to observe effects and safety outcomes.
CONDITIONS
Brief 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...
- Age 18 years or older
- Pathologically confirmed esophagogastric adenocarcinoma
- Diagnosis of metastatic or recurrent disease
- ECOG performance status of 0 or 1
- Life expectancy of at least 4 months
- Histologic diagnosis showing more than 25% of tumor expresses mesothelin
- Stage IV disease with peritoneal carcinomatosis confirmed by imaging or cytology
- Disease progression or intolerance after at least one prior metastatic treatment
- Patients with Her2 positive disease must have received at least one anti-Her2 therapy
- At least one measurable or evaluable lesion per RECIST 1.1
- Completion of systemic therapy at least 7 days before leukapheresis
- Lab requirements for blood counts and chemistry within specified limits
- Negative infectious disease screening
- Negative pregnancy test and agreement to use contraception (if applicable)
- Resolution of acute toxic effects from prior treatments to grade 1 or less except neuropathy and alopecia
- Written informed consent for the study
You will not qualify if you...
- Pregnant or lactating
- HIV infection or active hepatitis B or C infection
- Receiving treatment for another active malignancy except in situ skin cancers
- Known hematologic malignancy needing treatment in last 5 years
- Previous receipt of CAR T-cell or other cellular therapy
- Previous mesothelin-directed therapy
- Major abdominal surgery less than 28 days before enrollment
- Untreated or active central nervous system metastases requiring treatment
- Active autoimmune disease requiring systemic treatment within 1 year
- Use of high-dose corticosteroids or immunosuppressive treatment
- Serious cardiac conditions such as severe heart failure or recent myocardial infarction
- Active interstitial lung disease or pneumonitis requiring steroids
- Baseline oxygen saturation below 90% on room air
- Active infection requiring antibiotics 7 days before leukapheresis
- Receipt of live, attenuated vaccine within 8 weeks before lymphodepleting chemotherapy
- Other medical conditions that may interfere with study participation
- Noncompliance concerns with treatment or follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive an intraperitoneal infusion of autologous T cells genetically modified to express the M28z1XXPD1DNR CAR targeting mesothelin-positive esophagogastric adenocarcinoma with peritoneal carcinomatosis.
Visits scheduled according to treatment and monitoring protocols
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
P
Parastoo Dahi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here