AMLNCT05734898
NKG2D CAR-NK & r/rAML
A study testing NKG2D CAR-NK in people with AML, run by Zhejiang University at 2 sites in China.
Trial summary
This trial will explore the maximum tolerated dose（MTD）of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML in a dose-escalation manner, and observe the clinical safety and efficacy. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- AML
- What is being tested?
- NKG2D CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2023to Sep 2024
- Phase
- Interventional
- 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 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥ 3 years old and ≤ 75 years old, male or female;
- Meet the diagnostic criteria for recurrent AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): leukemic cells reappear in peripheral blood or bone marrow MRD > 0.1% after complete remission (CR), including relapse after allogeneic hematopoietic stem cell transplantation or extramedullary leukemic cell infiltration.
- Meet the diagnostic criteria for refractory AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;
- Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;
- Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
- Life expectancy ≥ 12 weeks from the time of enrollment;
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- The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL≦3ULN, AST≦2.5ULN, ALT≦2.5ULN; (3) Renal function: Cr≦1.25ULN;
- Flow cytometry check for NKG2D ligand expression on the surface of cancer cells as a reference for patient selection;
- The patient's peripheral superficial vein is accessible for IV insertion and blood draws;
- No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);
- No history of other malignant tumors;12. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
- 13. Subjects have negative HIV, HBV, HCV, syphilis serology test results; 14. Written informed consent form must be signed by the patient or the patient's immediate family members before enrollment.
Who cannot join
- Acute promyelocytic leukemia (Type M3);
- Patients with cardiac insufficiency, patients with liver and renal insufficiency;
- Patients with other malignant tumors need to be treated;
- Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment;
- Patients suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for enrollment);
- Patients with diffuse vascular internal coagulation;
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- Patients with concomitant serious infection or other serious underlying medical condition;
- Patients with variable immunodeficiency and autoimmune diseases;
- Patients who have severe allergic diseases;
- Clinical symptoms of brain dysfunction or severe mental illness that can not understand or follow the research protocol;
- Have participated in clinical trials of other drugs within 4 weeks or within 21 days of surgery;
- Have received cell therapy in the previous 1 month;
- Have received hormonal drug therapy in the previous 14 days;
- Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection or syphilis;
- Have received organ transplants (excluding stem cell transplant patients);
- Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study;
- Pregnant or lactating women;
- Those who cannot be followed up as scheduled;
- Patients, who in the opinion of the investigator, have any clinical or laboratory abnormalities or compliance problems and are not suitable to participate in this clinical study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
Yongxian HU, MD, +86-0571-87236476, huyongxian2000@aliyun.com
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, MD, 86-13605714822, hehuangyu@126.com
About this study
Official title: NKG2D CAR-NK Cell Therapy for the Treatment of Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
This trial will explore the maximum tolerated dose（MTD）of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML in a dose-escalation manner, and observe the clinical safety and efficacy.
- Conditions
- AML
- Being tested
- NKG2D CAR-NK
- Keywords
- CAR-NK, NKG2D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKG2D CAR-NKBiological
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion
| Study group | Role | What they receive |
|---|---|---|
| rrAML | Experimental | Not described Receives: Biological: NKG2D CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-Limiting Toxicity
Measured: 28 days
MTD
Maximal Tolerable Dose
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Cheetah Cell Therapeutics Co., Ltd
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734898
- Sponsor's protocol ID
- [2023]TXB--001
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 3 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NKG2D CAR-NK Cell Therapy for the Treatment of Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05734898
- Acronym / sponsor ID
- [2023]TXB--001
- Conditions
- AML
- Keywords
- CAR-NK, NKG2D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Cheetah Cell Therapeutics Co., Ltd
- Study start
- Mar 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Feb 2023 (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.
This trial will explore the maximum tolerated dose（MTD）of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML in a dose-escalation manner, and observe the clinical safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rrAML | Experimental | Biological: NKG2D CAR-NK |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age: ≥ 3 years old and ≤ 75 years old, male or female;
- Meet the diagnostic criteria for recurrent AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): leukemic cells reappear in peripheral blood or bone marrow MRD > 0.1% after complete remission (CR), including relapse after allogeneic hematopoietic stem cell transplantation or extramedullary leukemic cell infiltration.
- Meet the diagnostic criteria for refractory AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;
- Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;
- Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
Key exclusion criteria (19 listed)
- Acute promyelocytic leukemia (Type M3);
- Patients with cardiac insufficiency, patients with liver and renal insufficiency;
- Patients with other malignant tumors need to be treated;
- Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment;
- Patients suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for enrollment);
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 |
|---|---|---|
| NKG2D CAR-NKLymphodepleting chemotherapy followed by NKG2D CAR-NK infusion | Biological | rrAML |
Primary outcome
DLT
Time frame: 28 days
Dose-Limiting Toxicity
MTD
Time frame: 28 days
Maximal Tolerable Dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NKG2D CAR-NK in people with AML, run by Zhejiang University at 2 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 12 inclusion and 19 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 Hu YongXian (+86-0571-87236476, huyongxian2000@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 28 days). The study lists 2 primary outcomes in all. 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 Mar 2023.