Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care

Launched by NYAMDAVAA TUUL · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called combined immune cell therapy for patients with stage 4 colorectal cancer that has spread to other parts of the body and has not improved with standard treatments. The goal is to see how safe this therapy is, how it affects the immune system, and whether it can help patients whose cancer has not responded to previous therapies.

To participate in this study, patients must have a specific type of colorectal cancer called adenocarcinoma and at least one measurable tumor. They should have already tried standard treatments that didn’t work for them and need to be in relatively good health overall. Participants will need to provide a small amount of blood to help create the immune cells for the therapy. Those interested should be aware that the trial is not yet recruiting, so they will need to wait for it to start. Additionally, there are some health conditions, like certain infections or autoimmune diseases, that could prevent someone from joining the study.

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Eligibility criteria

• Inclusion Criteria:
• • Those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers
• • Those with at least one measurable or evaliable lesion by RECIST v1.1
• • Those who fail standard treatment for metastatic colorectal cancer (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process)
• • ECOG performance status 0 or 1 person
• • A person who can draw about 100 cc of whole blood for the manufacture of immune cells
• • Weight: More than 50 kg for men and more than 45 kg for women
• • Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed)
• • Appropriate contraceptive regimen up to 2 months after clinical research drug administration
• • A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing
• Exclusion Criteria:
• • Brain Metastasis patients who have symptoms or need treatment \[However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register\]
• • A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment
• • Those with the following cardio-cerebrovascular diseases as of the time of screening
• • a person who is HIV-positive
• • Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test
• • a person with acute or severe infection
• • Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases
• • Those with a history of organ transplants
• • a hematopoietic stem cell transplant patient