Clinical trial NCT05394714: A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Colon Cancer Stage I
Lead sponsor: Medigen Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 60 weeks
measure: Number of Participants With at Least One Dose Limiting Toxicity
timeFrame: Within 14-day observation of the first treatment. up to 60 weeks
measure: Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)
timeFrame: 3 weeks from start of treatment, up to 60 weeks
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 60 weeks
measure: Changes in Frequency and Duration of ctDNA
timeFrame: Up to 60 weeks
measure: Changes in Frequency and Duration of Circulating Tumor Count (CTC) and Programmed Death-Ligand 1 Circulating Tumor Count (PD-L1+ CTC) counts
timeFrame: Up to 60 weeks
measure: Changes in Biomarkers (CEA and CA19-9)
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Medigen Biotechnology Corporation
name: Stanley Chang, PhD
role: STUDY_CHAIR
References: