Trial | NCT02882659  Report issue

Title

Dendritic Killer Cell-based Immunotherapy for Solid Tumors
Phase I Clinical Trial of Autologous Dendritic Killer Cell-based Immunotherapy for Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    18
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
Study Started
Aug 31
2014
Primary Completion
Jan 31
2016
Study Completion
Dec 31
2017
Anticipated
Last Update
Aug 30
2016
Estimate

Biological Dendritic Killer Cell (DKC)

DKC is a hybrid cell type capable of dual functionality, i.e. cytotoxicity and antigen presentation, similar to NK cells and DCs, respectively.

  • Other names: FullHope Cell Therapy A (FHCTA)

Dendritic Killer Cell (DKC) Experimental

All enrolled patients received one treatment cycle of DKC cell therapy, which consists of 5 infusion cycles approximately 23 days apart. There were 3 dose levels: 5 x 10^6, 1 x 10^7, and 5 x 10^7 cells, and the protocol followed a traditional 3+3 dose escalation design.

Criteria 

Inclusion Criteria:

Capable and willing of providing signed informed consent before study
Patient age ≥20 at date of consent
Performance status (ECOG) ≤2
Patients have a life expectancy of > 3 months
Patients agree to be in compliant to clinical protocol planned treatment plan
Histologically confirmed metastatic solid tumor, including colon cancer, gastric cancer, pancreatic cancer, bile duct cancer, liver cancer
Patient with histological and conventional imaging proven measurable lesion
Patients not pregnant. All male and female patients with reproduction ability should use appropriate contraception method(s) during the study period
Patient is not currently under immunosuppressive treatment for previous or recurred autoimmune disease
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)

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

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
Patient showing negative response in syphilis, HIV, HBV and HCV test

Exclusion Criteria:

Any other investigational drug used within 28 days prior to first DKC administration
Patient with known brain metastasis or metastasis to central nervous system
Patient with pulmonary fibrosis
Patient with pleural effusion or as cites correspond to CTCAE grading > 2
Patient with uncontrolled disease including but not limit to cardiovascular disease, liver disease, renal disease or infectious disease
Patients being diagnosed with any cognitive or psychiatric illness
Patient not suitable to participate the trial for safety concerns as judged by the investigator
No Results Posted