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Colorectal NeoplasmsPhase 1NCT02882659

Dendritic Killer Cell-based Immunotherapy for Solid Tumors

A Phase 1 study testing Dendritic Killer Cell (DKC) in people with Colorectal Neoplasms and Hepatocellular Carcinoma, run by FullHope Biomedical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Dendritic Killer Cell (DKC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
Aug 2014to Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

About this study

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

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

Being tested
Dendritic Killer Cell (DKC)
Keywords
Clinical Trial, Phase I
Medical subject headings
Colorectal Neoplasms, Carcinoma, Hepatocellular, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic Killer Cell (DKC)Biological

    Also called 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.

Study groups in NCT02882659
Study groupRoleWhat they receive
Dendritic Killer Cell (DKC)ExperimentalAll 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.
Receives: Biological: Dendritic Killer Cell (DKC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of DKC as assessed by adverse event (AE)

    The coding system used for AE is MedDRA. Only treatment-emergent adverse events (TEAEs) are considered for primary endpoint. Frequency table of subjects with pre-treatment and treatment-emergent AE are presented by each cohort and overall trial. AE incidents are summarized descriptively by system organ class and preferred term using MedDRA for each cohort and overall trial.

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

  2. Safety of DKC as assessed by serious adverse event (SAE)

    Serious adverse event incidence is summarized descriptively by system organ class and preferred term for each cohort and overall trial. The causality of SAEs will be assessed by the principal investigator for its relationship to study medication.

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

  3. Safety of DKC as assessed by dose-limiting toxicity (DLT)

    DLT is defined as Grade ≧ 3 (according to NCI-CTCAE 4.03 grading system), study medication-related (i.e. with causality determined as at least possibly related to study medication), and worsened in comparison to baseline (pre-treatment condition). DLT is determined after first infusion cycle and maximum tolerated dose (MTD) is determined as the highest dose without DLT. DLT is defined by the items listed below:

    Blood and lymphatic system disorders: Grade ≧ 3 of (1) Any febrile neutropenia, (2) Leukocytosis, (3) Anemia

    Other disorders: Grade ≧ 3 of (1) Diarrhea, (2) Vomiting, (3) Fever, (4) Nausea, (5) Anaphylaxis

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

  4. Safety of DKC as assessed by combining with concomitant anticancer treatment

    The subjects enrolled in the study are cancer patients, who were treated with anticancer drugs before, and possibly during, DKC immunotherapy. Potential adverse drug-drug interaction (DDI) is monitored during treatment and follow-up period.

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

  5. Safety of DKC as assessed by laboratory examinations

    For each cohort, there are 5 baselines (taken 9 days before infusion) for 5 infusion cycles, and there are 2 evaluation time points in each infusion cycle (at end of first week and second week after infusion) and 4 in the follow-up period (at every 12 weeks). The laboratory evaluation results are tabulated in two aspects: 1) the percentage changes between each evaluation and corresponding baselines, and 2) the mean baseline values of each cycle in each cohort. Laboratory results regarding different functional categories are described separately in following areas.

    Hematology related items: Hb (g/dL), WBC (count/uL), Platelet (x 10^3 count/uL), ANC (count/uL)

    Liver function related items: C-RP (mg/dL), Glucose AC (mg/dL), Total Bilirubin (mg/dL), AST (U/L), ALT (U/L), LDH (U/L), ALP (U/L), gammaGT (U/L)

    Serum lipids and proteins, renal function, and electrolytes related items: HDL-C (mg/dL), Total Cholesterol (mg/dL), Triglyceride (mg/dL), Creatinine (mg/dL), BUN (mg/dL)

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

Secondary outcomes (2)

  1. Efficacy of DKC as assessed by tumor specific T cell response

    The tumor specific T cell response was assessed by the detection of CD3+CD8+CD69+IFN-gamma+ T lymphocytes in percentage relative to total peripheral blood mononuclear cells (PBMCs). Baseline value was measured before first infusion cycle, and subsequent evaluation time points were measured right after infusion cycles 2, 3, and 4.

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days)

  2. Efficacy of DKC as assessed by change in quality of life

    The quality of life as assessed by the WHO QoL-BREF questionnaire, and the transformed scores (0-100) was used to facilitate the interpretation. Baseline value was measured before first infusion cycle, and evaluation time points were taken right after infusion cycles 2, 3, 4, and 5. During the follow-up period, evaluation time points were taken at every 12 weeks for a total of 4 time points.

    Measured: Entire treatment period (cycle 1-5, 116 +/- 4 days) and follow-up period (452 +/- 4 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionJan 2016
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882659
Sponsor's protocol ID
2013-07-026B
Status last verified
Aug 2016
First submitted
18 Aug 2016
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dendritic Killer Cell (DKC) in people with Colorectal Neoplasms and Hepatocellular Carcinoma, run by FullHope Biomedical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02882659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.

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