Clinical trial NCT02882659: Dendritic Killer Cell-based Immunotherapy for Solid Tumors
Official title: Phase I Clinical Trial of Autologous Dendritic Killer Cell-based Immunotherapy for Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Colorectal Neoplasms
Hepatocellular Carcinoma
Neoplasm Metastasis
Keywords: Clinical Trial, Phase I
Lead sponsor: FullHope Biomedical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2016-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety of autologous dendritic killer cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination, assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE). The secondary endpoints regarding efficacy includes the generation of tumor specific immune response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of life


Eligibility criteria: Inclusion Criteria:

1. Capable and willing of providing signed informed consent before study
2. Patient age ≥20 at date of consent
3. Performance status (ECOG) ≤2
4. Patients have a life expectancy of \> 3 months
5. Patients agree to be in compliant to clinical protocol planned treatment plan
6. Histologically confirmed metastatic solid tumor, including colon cancer, gastric cancer, pancreatic cancer, bile duct cancer, liver cancer
7. Patient with histological and conventional imaging proven measurable lesion
8. Patients not pregnant. All male and female patients with reproduction ability should use appropriate contraception method(s) during the study period
9. Patient is not currently under immunosuppressive treatment for previous or recurred autoimmune disease
10. Patient should have received and failed prior standard cancer therapies (according to TVGH standard cancer treatment procedures, or National Comprehensive Cancer Network clinical practice guidelines in oncology)
11. Patient with adequate hematology function:

    Absolute neutrophil count (ANC) ≥ 1,500 cells Total white blood cell (WBC) ≥ 3,000 cells /mm3 Hemoglobin ≥ 9 g/dl Platelets ≥ 100,000 counts /mm3
12. Patient with adequate hepatic and renal function Serum creatinine ≤ 1.5X Upper Limit of Normal (ULN) Total bilirubin (TB) ≤ 1.5X ULN, or ≤ 2.5X ULN for patients with primary HCC or liver metastasis ALT and AST ≤ 2.5X ULN, or ≤ 5X ULN for patients with primary HCC or liver metastasis Alkaline phosphatase (ALP) ≤ 5X ULN
13. Patient showing negative response in syphilis, HIV, HBV and HCV test

Exclusion Criteria:

1. Any other investigational drug used within 28 days prior to first DKC administration
2. Patient with known brain metastasis or metastasis to central nervous system
3. Patient with pulmonary fibrosis
4. Patient with pleural effusion or as cites correspond to CTCAE grading \> 2
5. Patient with uncontrolled disease including but not limit to cardiovascular disease, liver disease, renal disease or infectious disease
6. Patients being diagnosed with any cognitive or psychiatric illness
7. Patient not suitable to participate the trial for safety concerns as judged by the investigator

Primary outcomes:
measure: Safety of DKC as assessed by adverse event (AE)
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
measure: Safety of DKC as assessed by serious adverse event (SAE)
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
measure: Safety of DKC as assessed by dose-limiting toxicity (DLT)
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
measure: Safety of DKC as assessed by combining with concomitant anticancer treatment
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
measure: Safety of DKC as assessed by laboratory examinations
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Secondary outcomes:
measure: Efficacy of DKC as assessed by tumor specific T cell response
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days)
measure: Efficacy of DKC as assessed by change in quality of life
timeFrame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veteran General Hospital, Taiwan R.O.C.
name: Yee Chou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: