Safety and EfficacyNCT05247957
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A study testing CAR-NK cells in people with Safety and Efficacy, run by Hangzhou Cheetah Cell Therapeutics Co., Ltd at 1 site in China.
Trial summary
This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- CAR-NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2021to 20 Dec 2022
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥ 10 years old and ≤ 75 years old, male or female;
- Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or >0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells;
- 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;
- Estimated survival > 3 months
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- Flow cytometry check for NKG2D ligand expression on the surface of cancer cells for a reference of selecting patients
- 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;
- The patient's peripheral superficial vein can meet the needs of intravenous injection;
- No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);
- No history of other malignant tumors;
- 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;
- Subjects have negative HIV, HBV, HCV, syphilis serology test results
- Written informed consent form must be signed before enrollment.
Who cannot join
- Acute promyelocytic leukemia (type M3);
- Patients with cardiac insufficiency, patients with hepatic and renal insufficiency;
- Those who need treatment with other malignant tumors;
- 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;
- Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees);
- Diffuse vascular internal coagulation;
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- Concomitant serious infection or other serious underlying medical condition;
- Have immunodeficiency and autoimmune diseases;
- 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 HIV-positive patients or hepatitis B and C patients and syphilis patients;
- 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;
- Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.
Read the detailed description
This is a single arm, open-label, Phase 1 study initiated with 3 cohorts:
Cohort 1: 2×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 2: 6×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 3: 18×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7
- Conditions
- Safety and Efficacy
- Being tested
- CAR-NK cells
- Keywords
- NKG2D CAR-NK, Relapsed or Refractory Acute Myeloid Leukemia
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-NK cellsBiological
Also called NKG2DL-specific CAR-NK cells
NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7
| Study group | Role | What they receive |
|---|---|---|
| NKG2DL-specific CAR-NK cells | Experimental | Experimental: NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7 After preconditioning with chemotherapy, NKG2DL-specific CAR-NK cells will be evaluated Receives: Biological: CAR-NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity
To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion
Measured: 28 days
Maximal Tolerable Dose
tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia
Measured: 28 days
Secondary outcomes (1)
leukemia-free survival#LFS#
leukemia-free survival
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start13 Oct 2021
- Primary completion12 Dec 2022
- Study completion20 Dec 2022
Why it stopped: end
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EfficacyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Cheetah Cell Therapeutics Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, MD, Principal investigator, Hebei Yanda Lu Daopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247957
- Sponsor's protocol ID
- CARNK-001
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2022
- Last updated
- 13 Jan 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 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05247957
- Acronym / sponsor ID
- CARNK-001
- Conditions
- Safety and Efficacy
- Keywords
- NKG2D CAR-NK, Relapsed or Refractory Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hangzhou Cheetah Cell Therapeutics Co., LtdUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 21 Feb 2022 (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 of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.
Detailed description
This is a single arm, open-label, Phase 1 study initiated with 3 cohorts:
Cohort 1: 2×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 2: 6×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 3: 18×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NKG2DL-specific CAR-NK cells | Experimental | Biological: CAR-NK cellsExperimental: NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7 After preconditioning with chemotherapy, NKG2DL-specific CAR-NK cells will be evaluated |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Age: ≥ 10 years old and ≤ 75 years old, male or female;
- Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or >0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells;
- 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 hepatic and renal insufficiency;
- Those who need treatment with other malignant tumors;
- 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;
- Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees);
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 |
|---|---|---|
| CAR-NK cellsAlso: NKG2DL-specific CAR-NK cellsNKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7 | Biological | NKG2DL-specific CAR-NK cells |
Primary outcome
Dose-Limiting Toxicity
Time frame: 28 days
To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion
Maximal Tolerable Dose
Time frame: 28 days
tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia
1 secondary outcome
leukemia-free survival#LFS#
Time frame: 52weeks
Results and safety
The study was stopped early (reason given: end). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.
Peihua Lu, MD principal investigator
Hebei Yanda Lu Daopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-NK cells in people with Safety and Efficacy, run by Hangzhou Cheetah Cell Therapeutics Co., Ltd 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 14 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: stopped early, as of the sponsor's last update on 13 Jan 2023. 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.
Are results available for this study?
The study was stopped early (reason given: end). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (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 13 Jan 2023.