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Hepatocellular CarcinomaPhase 1NCT01914263

Safety Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection

A Phase 1 study testing cytokine induced killer cell in people with Hepatocellular Carcinoma and Renal Cell Carcinoma, run by Alliancells-PuRui Biocience Co., Ltd. at 3 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a major histocompatibility complex-unrestricted antitumor activity. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
cytokine induced killer cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
Mar 2014to Jun 2016
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female patients over 18 years of age.
  • Patients who give written informed consent.
  • Patients with solid tumor already had radical resection
  • Definition of radical resection in this study:
  • All tumors were moved out, with a clean resection margin.
  • No distance metastasis.
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  • No major post-operative complication.
  • Without any anti-cancer medication within the past 15 days.
  • The following laboratory parameters: Platelet count >= 70 x 109/L; Hemoglobin >= 8.5 g/dL; Albumin >= 3.5 g/dL; Total bilirubin <= 25umol/L; Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal; Serum creatinine <= 1.5 x the upper limit of normal; Prothrombin time (PT) <= 3 seconds above control.

Who cannot join

  • History of cardiac disease.
  • Active clinically serious infections
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • History of organ allograft.
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  • Known or suspected allergy to the investigational agent or any agent given in association with this trial.
  • Pregnant or breast-feeding patients.
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.

Trial locations and contacts

3 sites in 1 country.

liming wang, MD contact

86-29-84756502

wanglm@fmmu.edu.cn

China3 sites, 3 recruiting

  • The 210 Hospital of Chinese People's Liberation Army

    Dalian, Liaoning, 116021

    Dayue Han, MD, 86-13387854002, tc210dl@hotmail.com

    Dayue Han, MD

    Recruiting

  • Hannan BOAO Life infinity international anti-aging medical center

    Qionghai, Hainan, 571434

    Recruiting

  • The 323 Hospital of Chinese People's Liberation Army

    Xi'an, Shaanxi, 710054

    Liming wang, MD, 86-29-84756502, wanglm@fmmu.edu.cn

    Liming Wang, MD

    Recruiting

Other trials in China

About this study

Official title: Phase 1 Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection

Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a major histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good therapy for patients with solid tumor.However, tumor relapse is still a risk for those patients. Our hypothsis is that cytokine induced killer cells maybe decrease the recurrence rate. The purpose of this study is to evaluate the safety and tolerability of cord blood-derived cytokine induced killer cells in patients with solid tumor following radical resection.

Read the detailed description

It was estimated that 2.6 million people suffer from cancer and 1.8 million die of cancer in China yearly according to the Annual Report of Cancer Registration in China 2012. So far, the main treatment modalities for tumors have been surgery, radiotherapy and chemotherapy. However, tumor relapse is still a risk for those patients underwent the conventional therapy. With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients. Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a MHC-unrestricted antitumor activity. CIK cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture.

Autologous CIK cells infusion therapy for patients with malignancies is reported world widely. However, there are several drawbacks for autologous CIK limiting its clinical application. For example, limited cell numbers, decreased cell activities, and unavailable in time etc. Cord blood, as a novel source of non-senescent lymphocytes for tumor immunotherapy, has been focused on recently. Accumulating preclinical studies have shown that cord blood-derived CIK cells are potent anti-tumor effectors using in adoptive cancer immunotherapy. However it is unclear whether administration of cord blood-derived CIK cells is safe in patients with malignancies. Our previous studies demonstrated that clinical scale expansion of CIK from cord blood is feasible. The cord blood-derived CIK cells exhibit antitumor effect in vitro and in vivo (tumor bearing nude mice) against a variety of tumor cells including ZR751, MCF7, HepG2, SMMC-7721, Hela, A375, DU145, H1299 and A549. Furthermore, intravenous infusion of a single dose of 3X10^8 cord blood-derived CIK cells in mice is safe.

The purpose of this study is to evaluate the safety and tolerability of cord blood-derived CIK cells in patients with solid tumor following radical resection.

Being tested
cytokine induced killer cell
Keywords
Cord blood-Derived cytokine induced killer cells,, Radical resection
Medical subject headings
Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Lung Neoplasms

What participants receive

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

  • cytokine induced killer cellBiological

    The eligible patients are infused with a single dose of 8x10^9 cord blood-derived cytokine indued killer cells.

Study groups in NCT01914263
Study groupRoleWhat they receive
cytokine induced killer cellExperimentalThe eligible patients are infused a single dose of 8x10^9 CIK cells.
Receives: Biological: cytokine induced killer cell
ControlNo interventionThe eligible patients are followed up for 30 days without any treatment.

What is being measured

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

  1. The incidence of adverse events following infusion of cord blood-derived cytokine-induced killer cells.

    The primary outcome measures for safety will include the incidence of fever,chill,rash and Graft-versus-Host Disease (GVHD).

    Measured: 30 days post-infusion

Secondary outcomes (2)

  1. Haematology

    These parameters include erythrocytes, leukocytes, platelets, T cell, B cell, Natural killer cell, CD4/CD8, Th1/Th2, Th17 cell and Treg cell.

    Measured: Baseline, 1 day, 3 days 10 days and 30 days after cell infusion

  2. Serological analysis

    immunoglobulin G, immunoglobulin A, immunoglobulin D, immunoglobulin E and immunoglobulin M. Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB); Blood urea nitrogen(BUN), Urea (UA), and Crea (Cr); Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;

    Measured: Baseline, 1day, 3 days 10 days and 30 days after cell infusion

Timeline

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

  1. First posted2 Aug 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2016 (estimated)
  4. Study completionJun 2016 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01914263
Sponsor's protocol ID
AlliancellsPuRui-01
Status last verified
Jul 2014
First submitted
29 Jul 2013
Last updated
16 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cytokine induced killer cell in people with Hepatocellular Carcinoma and Renal Cell Carcinoma, run by Alliancells-PuRui Biocience Co., Ltd. at 3 sites in China.

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 9 inclusion and 10 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact liming wang, MD (86-29-84756502, wanglm@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse events following infusion of cord blood-derived cytokine-induced killer cells. (time frame: 30 days post-infusion). 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 NCT01914263.

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 16 Apr 2015.

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