Overview

This trial is active, not recruiting.

Conditions colorectal neoplasms, hepatocellular carcinoma, neoplasm metastasis
Treatment dendritic killer cell (dkc)
Phase phase 1
Sponsor FullHope Biomedical Co., Ltd.
Collaborator Taipei Veterans General Hospital, Taiwan
Start date August 2014
End date January 2016
Trial size 18 participants
Trial identifier NCT02882659, 2013-07-026B

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
dendritic killer cell (dkc) FullHope Cell Therapy A (FHCTA)
DKC is a hybrid cell type capable of dual functionality, i.e. cytotoxicity and antigen presentation, similar to NK cells and DCs, respectively.

Primary Outcomes

Measure
Safety of DKC as assessed by adverse event (AE)
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Safety of DKC as assessed by serious adverse event (SAE)
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Safety of DKC as assessed by dose-limiting toxicity (DLT)
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Safety of DKC as assessed by combining with concomitant anticancer treatment
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)
Safety of DKC as assessed by laboratory examinations
time frame: 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
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days)
Efficacy of DKC as assessed by change in quality of life
time frame: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Phase I Clinical Trial of Autologous Dendritic Killer Cell-based Immunotherapy for Solid Tumors
Principal investigator Yee Chou, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by FullHope Biomedical Co., Ltd..