An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients (CCT-ANK-11)

April 14, 2024 updated by: Beijing Kejing Biotechnology Co., Ltd.
An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient agrees to complete the entire treatment plan and sign the informed consent form.
  2. Age 18 to 65, male or female.
  3. Malignancy confirmed by histology or imaging diagnosis (computer tomography (CT), magnetic resonance imaging (MRI), contrast-enhanced ultrasound, EOB-MRI), the malignant solid tumor was completely resected (R0).
  4. Patients who have received surgical treatment 4-8 weeks before the screening period.
  5. Quality of life assessment form (ECOG) score 0,2.
  6. Child-Pugh score of liver function ≤ 7.
  7. The life expectancey is more than 6 months.
  8. Patients with appropriate hematological functions:

（1）White blood cell (WBC) ≥ 3000 cells / mm3. （2）Absolute neutrophil count (ANC) ≥ 1500 cells.

（3）Platelet count (Platelets) ≥ 80000/mm3. （4）Hemoglobin (Hb) ≥ 9g/dl. 9. Patients with appropriate liver and kidney functions:

（1）Urea nitrogen (BUN) ≤ 1.5 times of the upper limit of normal value (ULN).（2）Serum creatinine (serumcreatinine) ≤ 1.5 times of the upper limit of normal value (ULN).（3）Total bilirubin (TB) ≤ 1.5 times of the upper limit of normal value (ULN).（4）Glutamic pyruvic transaminase (ALT or GPT) and glutamic oxaloacetic transaminase (AST or GOT) ≤ 2.5 times the upper limit of normal value (ULN).

10. Patients who have tested negative for syphilis and AIDS. 11.Patient with active hepatitis B, can take antiviral drugs during the trial period.

twelve。 Fertile men and women must use effective contraception within 14 days after signing the informed consent form and within 14 days after the last dose of natural killer cells are infused.

13. At least two forms of birth control must be used, one of which must be a barrier method. Acceptable contraceptive measures include:

（1）Establish oral, injection or implanted hormone contraceptive methods.（2）Placement of intrauterine device (IUD) or intrauterine system (IUS).（4）Barrier method: condom or occlusive cap (contraceptive diaphragm or cervical / uterine cap).

14. The patient agrees to comply to the trial rpotocols.

Exclusion Criteria:

  1. Patients received drugs or other cellular immunotherapy in other clinical trials within 28 days before the screening period.
  2. Patients are receiving immunosuppressive therapy for previous or recurrent autoimmune diseases within 14 days before allogeneic natural killer cell infusion.
  3. The patient suffered from other malignant tumors in the past 5 years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
  4. Acute illness in progress, or has been accompanied by serious diseases in the past 2 years, such as cardiovascular disease (such as New York Heart Association (NYHA) III or IV), mental health problems (e.g. alcohol, drug abuse). Or the program moderator judges patients who are not suitable to participate in clinical trials on the basis of medical history, physical examination results or test abnormalities that may interfere with the test results or adversely affect the safety of the subjects.
  5. Allergic to aminoglycosides (Aminoglycoside) or subtilisin (Bacitracin), such as streptomycin (Streptomycin) and gentamicin (Gentamicin).
  6. Patient is known to be allergic to any ingredient in the end product of NK preparation, including human serum albumin.
  7. Female subjects who are breast-feeding or positive for serum or urine pregnancy tests during the screening period.
  8. Pretreatment with steroids or antihistamines cannot be controlled for radiographic contrast agents (iodinated or non-iodinated) who have a history of allergy or allergic reactions or other clinically significant adverse reactions, and the researchers believe that it is not suitable for subjects who undergo conventional computerized tomography (CT) or magnetic resonance imaging (MRI). And subjects with contraindications for CT scanning for other reasons (such as strong magnetic implants, severe claustrophobia) should not be included in the group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A group
Drug: Allogeneic NK（CCT-ANK-11)
allogeneic natural killer cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the safety and the efficacy
Time Frame: 12 months
To evaluate the safety and objective remission rate of multiple injections of allogeneic natural killer cells (complete remission [CR] + partial remission [PR])
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of anti-tumor response of allogeneic natural killer cells.
Time Frame: 12 months
TGF-β1、IL-2、IL-15
12 months
To evaluate the modulations of circulating tumor deoxyribonucleic acid (ctDNA) and circulating tumor cells (CTC).
Time Frame: 11months
The time of blood collection on the same day before the first chemotherapy was taken as the baseline, and then tested every three months.
11months
To assess the modulation in tumor markers
Time Frame: 11months
Pancreatic cancer: CA19-9、CA125. esophageal cancer: CA19-9、CEA、CA-724、CYFRA21、SCC. gastric cancer: CA19-9CEA、CA-724. Cholangiocarcinoma: AFP、CA19-9、CEA. Lung cancer: CEA、CA125、NSE、CYFRA21、ProGRP、SCC. Ovarian cancer: CA-125、CEA、AFP、β hCG、CA-724、HE4.
11months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Kejing Biotechnology Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Kejing Biotechnology Corp.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yinping Sun, medical oncology, Zibo Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCT-ANK-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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