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

Официальное название

A Dose-Escalating Phase I Study to Determine the Safety, and Maximum Tolerated Dose/ Maximum Feasible Dose of Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection

Обзор

This is a Phase I, open-label study to explore the safety profile and to find the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Magicell-NK in subjects diagnosed with stage I or stage IIa colon cancer post resection from a single site in Taiwan. During this study, 3 dose levels of Magicell-NK will be tested with a 3+3 design to determine the MTD/MFD: Cohort 1, low dose (2×10\^8 cells), Cohort 2, middle dose (6×10\^8 cells), and Cohort 3, high dose (12\~18 ×10\^8 cells).

Вмешательства

• Биопрепарат Magicell-NK contains NK cells suspended in 100 mL normal saline
  Eligible subjects will be assigned into one of the three dose escalating cohorts (3+3 subjects/cohort) according to the time sequence enrolled

Первичные конечные точки

• Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 60 weeks]
• Number of Participants With at Least One Dose Limiting Toxicity [Срок оценки: Within 14-day observation of the first treatment. up to 60 weeks]
• Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) [Срок оценки: 3 weeks from start of treatment, up to 60 weeks]

Вторичные конечные точки (4)

• Disease free survival (DFS) [Срок оценки: Up to 60 weeks]
• Changes in Frequency and Duration of ctDNA [Срок оценки: Up to 60 weeks]
• Changes in Frequency and Duration of Circulating Tumor Count (CTC) and Programmed Death-Ligand 1 Circulating Tumor Count (PD-L1+ CTC) counts [Срок оценки: Up to 60 weeks]
• Changes in Biomarkers (CEA and CA19-9) [Срок оценки: Up to 60 weeks]

Критерии участия

Критерии включения

• A dated and signed informed consent
• Either gender and aged over 20 years old (inclusive) at date of consent
• With histologically confirmed stage I or stage IIa colon cancer
• Received curative colon resection within 4\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
• With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
• 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
• 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
• Negative response in HIV and syphilis test
• 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.
• Performance status (ECOG) < 2
• Patients agree to be in compliant to clinical protocol planned treatment plan

Критерии исключения

• 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.
• 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
• With known tumor metastasis or coexisting malignant disease
• 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
• Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
• Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
• Female subject who is lactating or has positive urine pregnancy test at screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Chang Gung Memorial Hospital, Linkou — Taoyuan

Идентификаторы

NCT: NCT05394714 · CT-NK-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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