MalignancyPhase 1/2NK cellNCT05143125
Treatment of Malignant Tumors With NK Cell
A Phase 1/2 study testing Decitabine combined with NK cell infusion in people with Malignancy, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignancy
- What is being tested?
- Decitabine combined with NK cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2021to Feb 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen University General hospital
Shenzhen, Guangdong, 518055
Shujiao He, Dr, +86-0755-2183-9178, he_shujiao@126.com
About this study
Official title: 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%.
Read the 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.
- Conditions
- Malignancy
- Being tested
- Decitabine combined with NK cell infusion
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine combined with NK cell infusionBiological
Decitabine combined with NK cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Decitabine combined with NK cell infusion as post-remission therapy Receives: Biological: Decitabine combined with NK cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
DFS
Measured: From date of initial treatment to the end of follow up, up to 2 years
Secondary outcomes (1)
Overall survival rate
OS
Measured: From admission to the end of follow up, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start5 Feb 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YuLi, Shenzhen University General Hospital
- Investigators
- Li Yu, Dr, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143125
- Sponsor's protocol ID
- HEM-ONCO-009
- Acronym
- NK cell
- Status last verified
- Feb 2021
- First submitted
- 22 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Decitabine Combined With NK Cell Infusion in the Treatment of Malignant Tumors
- ClinicalTrials.gov ID
- NCT05143125
- Acronym / sponsor ID
- NK cell / HEM-ONCO-009
- Conditions
- Malignancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Decitabine combined with NK cell infusionDecitabine combined with NK cell infusion as post-remission therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decitabine combined with NK cell infusionDecitabine combined with NK cell infusion | Biological | Treatment group |
Primary outcome
Disease-free survival
Time frame: From date of initial treatment to the end of follow up, up to 2 years
DFS
1 secondary outcome
Overall survival rate
Time frame: From admission to the end of follow up, up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yu, Dr principal investigator
Shenzhen University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Decitabine combined with NK cell infusion in people with Malignancy, run by Shenzhen University General Hospital at 1 site 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 6 inclusion and 11 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Li Yu, Dr (+8675521839178, liyu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: From date of initial treatment to the end of follow up, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2021.