Status:
TERMINATED
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
Hangzhou Cheetah Cell Therapeutics Co., Ltd
Conditions:
Safety and Efficacy
Eligibility:
All Genders
10-75 years
Phase:
NA
Brief 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 safe...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05247957
Start Date
October 13 2021
End Date
December 20 2022
Last Update
January 13 2023
Active Locations (1)
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1
Hebei Yanda Lu Daopei Hospital
Sanhe, Hebei, China