Human HER2-targeted Macrophages Therapy for HER2-positive Advanced Gastric Cancer With Peritoneal Metastases

Launched by FIRST PEOPLE'S HOSPITAL OF HANGZHOU · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for patients with advanced gastric cancer that tests positive for HER2, a protein that can promote cancer growth. The treatment involves using specially modified immune cells called macrophages, which are designed to target and fight the cancer. In this study, participants will have their bone marrow stem cells collected and then modified to boost their ability to attack the cancer. These modified cells will be infused back into the body to help fight tumors, particularly those that have spread to the abdominal area.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of HER2-positive gastric cancer, and have experienced treatment failure with prior therapies. They should also have measurable lesions and be in reasonably good health. The trial is not yet recruiting, but once it begins, participants can expect close monitoring throughout the study to ensure their safety and to track how well the treatment is working. It's important for potential participants to understand the study and be willing to follow the rules and procedures involved.

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Eligibility criteria

• Inclusion Criteria:
• • 1. age between 18 and 75 years (including borderline values), male or female.
• • 2. expected survival of more than 12 weeks.
• • 3. histologically confirmed HER2-positive gastric cancer; HER2-positive is defined as immunohistochemistry (IHC) 3+ or (IHC) 2+ with in situ hybridization (ISH) +.
• • 4. confirmation of peritoneal metastasis by imaging or cytologic testing of peritoneal fluid.
• • 5. presence of measurable lesions.
• • 6. patients with peritoneal metastases of gastric cancer who had previously failed second-line or higher therapy. Treatment failure is defined as an intolerable toxic reaction or disease progression during treatment or tumor recurrence or metastasis after completion of treatment. Prior therapy of targeted agents, immunosuppressants, or radiotherapy is permitted; prior systemic therapy with at least 1-2 chemotherapeutic agents of fluorouracil, platinum, and paclitaxel in combination with targeted agents.
• • 7. have an Eastern Cooperative Oncology Group (ECOG) activity status score of 0-2
• • 8. at least 2 weeks have elapsed since receiving the most recent drug therapy to the time of single nucleated cell collection.
• • 9. patients of childbearing age are required to use appropriate contraception (protection or other birth control) prior to enrollment and during the study.
• • 10. the patient is willing to accept intraperitoneal administration of the drug.
• • 11. the patient understands the trial and has signed an informed consent form.
• • 12. the patient is able to follow the study protocol and follow-up procedures.
• Exclusion Criteria:
• • 1. previous or current other types of malignant tumors, except for the following: completely resected or eradicated basal and squamous cell carcinoma of the skin, and carcinoma in situ of the cervix.
• • 2. patients requiring immunosuppressive drugs (except physiologic replacement doses).
• • 3. history of central nervous system (CNS) disorders such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; untreated or symptomatic CNS metastases or cytologically confirmed carcinomatous meningitis (asymptomatic CNS metastases that do not require treatment may be enrolled).
• • 4. left ventricular ejection fraction \<50%.
• • 5. White blood cell count \<3×10\^9/L and platelet count \<80×10\^9/L.
• • 6. AST and ALT \> 3 × upper limit of normal (ULN)
• • 7. Total bilirubin \> 1.5 × ULN.
• • 8. creatinine clearance \<60 ml/min.
• • 9. Abnormal coagulation function (activated partial thromboplastin time (APTT) \> 1.5 × ULN, international normalized ratio (INR) \> 1.5 × ULN).
• • 10. patients with intestinal obstruction (gastrointestinal obstruction within 30 days prior to administration).
• • 11. patients with infectious diseases including, but not limited to: 1) known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related disease; 2) known active liver disease, including hepatitis B and hepatitis C; 3) active tuberculosis infection, who are on anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year prior to the first dose of the study drug; 4) known syphilis infections requiring treatment; and 5) Other infectious diseases that, in the judgment of the investigator, make participation in this study unsuitable.
• • 12. Diseases that, in the judgment of the investigator, preclude enrollment: including, but not limited to, severe hepatic, renal, or metabolic disease requiring drug therapy, uncontrolled coronary artery disease or asthma, and uncontrolled cerebrovascular disease.
• • 13. pregnant or breastfeeding females; females or males of childbearing age with a pregnancy plan during the study.
• • 14. psychotropic substance abuse, clinical or psychological or social factors that would compromise informed consent or study conduct (at the discretion of the investigator).
• • 15. individuals who may be allergic to the study medication.
• • 16. is participating in another clinical trial.
• • 17. patients with inaccessible peripheral or deep venous access.
• • 18. any uncertainty that has an impact on patient safety or compliance.
• • 19. any other condition that the investigator considers inappropriate for enrollment.