A Study of IMC008 for Advanced Solid Tumors

Summary

An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.

Eligibility

Inclusion Criteria:

* Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
* Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
* The expected survival period of the subject is ≥12 weeks.
* The subject needs to have at least one target lesion that can be stably evaluated.
* The ECOG score is 0-1.
* Subject has adequate organ and bone marrow function
* All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1.
* Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
* Subjects must sign and date written informed consent.

Exclusion Criteria:

* Pregnant and lactating women.
* Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
* Serious infection that is active or poorly controlled clinically.
* Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
* Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
* Oxygen saturation ≤ 95% without oxygen inhalation.
* Suffering from other research diseases that may limit their participation in this study.
* Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
* There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
* Presence of any cardiac clinical symptoms or disorders.
* Evidence of significant coagulopathy or other significant bleeding risk.
* Received systemic steroids equivalent to \>15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.
* Prior or concurrent occurrence of other malignancies, with the following exceptions.
* Subjects who have previously received other gene therapy.
* Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC008.
* Subjects with severe mental disorders.
* The investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .

Conditions2

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