Study on TROP2 CAR/IL-15 TGFBR2 KO NK Cells for Treating Stomach Cancer Spread to the Abdominal Area
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT07509008
This clinical trial is testing a new treatment using modified immune cells delivered directly into the abdominal area to help manage stomach cancer that has spread to the peritoneum. The study aims to find the best dose and evaluate the safety and effectiveness of this approach.
Patient Parameters
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Program Overview
The purpose of this study is to determine the best dose of a new treatment involving TROP2 CAR/IL-15 TGFBR2 KO NK cells, which are special immune cells modified to target cancer. These cells are delivered directly into the abdominal area to treat stomach cancer that has spread there. Researchers will also study how safe and effective this treatment is for patients.
Description
This study is focused on finding the safest and most effective dose of TROP2 CAR/IL-15 TGFBR2 KO NK cells, which are specially modified immune cells. These cells are delivered directly into the abdominal area to target stomach cancer that has spread to the peritoneum. The study will monitor for any side effects and determine how well the treatment works in shrinking tumors.
The study will also look at how long patients live after receiving the treatment, how long the modified cells stay in the body, and how the cancer environment changes before and after treatment. Researchers will compare changes in tumor DNA in the blood with the response to treatment.
While the benefits of this treatment are not yet known, the study aims to provide a potential new option for managing this type of cancer. Patients will be closely monitored for their response to the treatment and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be willing and able to provide informed consent.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Women of childbearing potential must agree to use effective contraception during the study and for three months after.
- Must have a confirmed diagnosis of stomach or gastroesophageal junction cancer that has spread to the peritoneum.
- Must be at least four weeks from the last chemotherapy treatment before starting the study treatment.
- Must be willing to undergo a minor surgery to place a port for treatment and provide blood and fluid samples.
- Must have adequate organ function based on specific medical tests.
Exclusion Criteria
- Pregnant or breastfeeding women, or those planning to become pregnant during the study.
- Have received cancer treatment or investigational drugs within four weeks before starting the study treatment.
- Have had recent radiation therapy or a live vaccine within 30 days before the study.
- Currently participating in another clinical trial or using investigational devices.
- Have active brain metastases or certain autoimmune diseases.
- Have serious infections or uncontrolled HIV, hepatitis B, or hepatitis C.
- Have a history of severe allergic reactions to similar treatments.
- Have significant heart disease or bleeding disorders.
- Have medical conditions that would make participation unsafe, such as active peritonitis or extensive abdominal adhesions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UT MD Anderson | 77030 | Houston | Texas |
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