- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143125
Treatment of Malignant Tumors With NK Cell (NK cell)
November 22, 2021 updated by: YuLi, Shenzhen University General Hospital
Clinical Study of Decitabine Combined With NK Cell Infusion in the Treatment of Malignant Tumors
Natural killer cells (NK cells) are derived from bone marrow lymphoid stem cells, which are a type of lymphocytes that can non-specifically kill tumor cells and virus-infected cells without pre-sensitization.
NK cells can not only directly kill malignant diseased cells, but also participate in the regulation of immune cell response and play a role in a variety of tumor immunotherapy strategies.
The 2-year survival rate of NK cells combined with stem cell therapy for patients with hematological malignancies reached 36%, which is significantly higher than the 2-year survival rate (about 15%) of stem cell therapy alone, which can extend the disease-free survival period of leukemia patients by an average of 1.5 years.
Relapsed and refractory leukemia can achieve a complete remission rate of up to 40%.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Natural killer cells (NK cells) are derived from bone marrow lymphoid stem cells, which are a type of lymphocytes that can non-specifically kill tumor cells and virus-infected cells without pre-sensitization.
NK cells can not only directly kill malignant diseased cells, but also participate in the regulation of immune cell response and play a role in a variety of tumor immunotherapy strategies.
The 2-year survival rate of NK cells combined with stem cell therapy for patients with hematological malignancies reached 36%, which is significantly higher than the 2-year survival rate (about 15%) of stem cell therapy alone, which can extend the disease-free survival period of leukemia patients by an average of 1.5 years.
Relapsed and refractory leukemia can achieve a complete remission rate of up to 40%.
However, NK cell therapy alone or the use of autologous NK cells to treat solid tumors is not effective.
In clinical trials related to rectal cancer, esophageal cancer, kidney cancer, and gastric cancer, the clinical response of NK cell adoptive therapy is not good.
A phase II clinical study found that the disease control rate of patients with ovarian cancer and breast cancer after radiotherapy and chemotherapy can reach about 60% by NK cell infusion.
The main reason for the low treatment efficiency of solid tumors is related to the immunosuppressive effect of the tumor microenvironment.
Combination therapy is a potential breakthrough.
Researches targeting tumor immune microenvironment, targeting tumor cells and combined with NK cell therapy have shown tumor therapeutic potential.
NK cells combined with IgG1 antibody treatment of gastric cancer and colon cancer in about 50% of patients with partial remission, and 17% of patients are in stable condition.
In summary, the combined application of the demethylation drug DAC and NK cell infusion may be a new clinical strategy for the treatment of malignant tumors.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- 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
- Name: Li Yu, Dr
- Phone Number: +8675521839178
- Email: liyu@vip.163.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518055
- Recruiting
- Shenzhen university General Hospital
-
-
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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients aged 18-70 (including 18 and 70 years old);
- Those who have been diagnosed as malignant tumor by pathological and histological examination, have received anti-tumor treatment and are in remission;
- The ECOG score of the patient is less than 2 points;
- The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-tumor treatments within 4 weeks before enrollment, and his previous treatment-related toxicity had returned to grade <1 (hair loss, peripheral nerves) at the time of enrollment Except for low-level toxicity such as inflammation);
- The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip;
- The patient voluntarily participates and signs an informed consent form, and follows the research treatment plan and visit plan.
Exclusion Criteria:
- The patients used high-dose hormones within 1 week before enrollment (except for patients using inhaled hormones);
- People with severe autoimmune diseases, immunodeficiency diseases or severe allergies;
- Patients who have been treated with other cellular immune products (DC, T, CTL, CAR-T, etc.);
- The patient had an uncontrollable infection within 4 weeks before enrollment;
- Active B HBV DNA>1000copy/mL/C virus hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive;
- The patient has participated in other clinical studies within 6 weeks before enrollment;
- Patients suffering from mental illness;
- The patient has drug abuse/addiction and medical, psychological or social conditions that may interfere with research or have an impact on the evaluation of research results;
- The patient has alcohol dependence;
- Women who are pregnant (positive urine/blood pregnancy studies) or breastfeeding; men or women who have a pregnancy plan within the past year; patients cannot be guaranteed to take effective contraceptive measures during the study period;
- According to the judgment of the investigator, the patient has other conditions that are not suitable for enrollment.
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Decitabine combined with NK cell infusion as post-remission therapy
|
Decitabine combined with NK cell infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: From date of initial treatment to the end of follow up, up to 2 years
|
DFS
|
From date of initial treatment to the end of follow up, up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival rate
Time Frame: From admission to the end of follow up, up to 2 years.
|
OS
|
From admission to the end of follow up, up to 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 5, 2021
Primary Completion (Anticipated)
February 1, 2024
Study Completion (Anticipated)
February 1, 2024
Study Registration Dates
First Submitted
November 22, 2021
First Submitted That Met QC Criteria
November 22, 2021
First Posted (Actual)
December 3, 2021
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
November 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEM-ONCO-009
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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