A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study

Launched by MEDIGEN BIOTECHNOLOGY CORPORATION · May 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Magicell-NK for patients with stage I or stage IIa colon cancer who have recently undergone surgery to remove their tumors. The main goals of the trial are to understand how safe this treatment is and to find out the highest dose that patients can tolerate without serious side effects. The researchers will test three different dose levels to see how each one works.

To participate in this study, patients must be over 20 years old, have a confirmed diagnosis of stage I or stage IIa colon cancer, and have had surgery to remove their cancer within the last 4 to 8 weeks. They should not need additional treatments like chemotherapy or radiation at this time. Participants will receive the Magicell-NK infusion and will be monitored for any side effects. It's important for potential participants to know that they will need to follow specific health guidelines and have certain blood tests to ensure they are eligible for the study. This trial is currently recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A dated and signed informed consent
• • 2. Either gender and aged over 20 years old (inclusive) at date of consent
• • 3. With histologically confirmed stage I or stage IIa colon cancer
• • 4. Received curative colon resection within 4\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
• • 5. With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
• 6. With adequate hematology function:
• • Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
• • Total white blood cell (WBC) ≥ 3,000 cells/μL
• • Platelets ≥ 100,000 counts/μL
• • Hemoglobin ≥ 9 g/dL
• 7. With adequate hepatic and renal function:
• • Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)
• • Total bilirubin (TB) ≤ 1.5 × ULN
• • ALT and AST ≤ 2.5 × ULN
• • Alkaline phosphatase (ALP) ≤ 5X ULN
• • 8. Negative response in HIV and syphilis test
• • 9. Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final/ET Visit.
• • 10. Performance status (ECOG) \< 2
• • 11. Patients agree to be in compliant to clinical protocol planned treatment plan
• Exclusion Criteria:
• • 1. Received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only), or immune cell therapy within 28 days prior to Day 1.
• • 2. Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1
• • 3. With known tumor metastasis or coexisting malignant disease
• • 4. With ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject
• • 5. Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
• • 6. Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
• • 7. Female subject who is lactating or has positive urine pregnancy test at screening