Recruiting NCT05394714
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magicell-NK contains NK cells suspended in 100 mL normal saline.
- Who it may be relevant to
- Registry conditions: Colon Cancer Stage I. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Biological 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
Primary outcome measures
- Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 60 weeks]
- Number of Participants With at Least One Dose Limiting Toxicity [Time frame: Within 14-day observation of the first treatment. up to 60 weeks]
- Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) [Time frame: 3 weeks from start of treatment, up to 60 weeks]
Secondary outcome measures (4)
- Disease free survival (DFS) [Time frame: Up to 60 weeks]
- Changes in Frequency and Duration of ctDNA [Time frame: 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 [Time frame: Up to 60 weeks]
- Changes in Biomarkers (CEA and CA19-9) [Time frame: Up to 60 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital, Linkou — Taoyuan
Identifiers
NCT: NCT05394714 · CT-NK-11