Dendritic Killer Cell-based Immunotherapy for Solid Tumors

FullHope Biomedical

Status and phase: Unknown; Phase 1

Conditions: Hepatocellular Carcinoma; Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Biological: Dendritic Killer Cell (DKC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02882659

2013-07-026B

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Dendritic Killer Cell (DKC)

Experimental group

Description:

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.

Treatment:

Biological: Dendritic Killer Cell (DKC)