Clincosm LogoSign in Get a demo

NKG2D CAR-NK Cell for Patients With r/rAML

Sponsor
Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05734898
Collaborator
Hangzhou Cheetah Cell Therapeutics Co., Ltd (Other)
9
Enrollment
2
Locations
1
Arm
19
Anticipated Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML. The primary endpoints are dose limiting toxicity (DLT) and Maximal tolerability evaluation (MTD).

Condition or Disease Intervention/Treatment Phase
  • Biological: NKG2D CAR-NK
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NKG2D CAR-NK(Natural Killer) Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: rrAML

Biological: NKG2D CAR-NK
Lymphodepleting chemotherapy followed by NKG2D CAR-NK infusion

Outcome Measures

Primary Outcome Measures

  1. DLT [28 days]

    Dose-Limiting Toxicity

  2. MTD [28 days]

    Maximal Tolerable Dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age: ≥ 3 years old and ≤ 75 years old, male or female;

  2. Meet the diagnostic criteria of recurrent AML Chinese guidelines for diagnosis and treatment of recurrent Refractory Acute Myeloid Leukemia (2017 Edition): 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.

  3. Chinese guidelines for diagnosis and treatment of recurrent and Refractory Acute Myeloid Leukemia (2017 Edition) according to the diagnostic criteria of refractory AML: initial cases who were ineffective after 2 courses of treatment with standard regimen; those who relapsed within 12 months after consolidation and intensive therapy after CR; those who relapsed within 12 months but were ineffective after routine chemotherapy; those who relapsed for 2 or more times; those with persistent extramedullary leukemia;

  4. At present, there is no effective treatment, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or voluntary infusion of NKG2DCAR-NK cells as the first treatment.

  5. The physical strength evaluation (ECOG-PS) of the eastern oncology collaboration group was 0-2;

  6. The estimated survival time is > 3 months;

  7. The expression of NKG2D ligand on the surface of cancer cells was detected by flow cytometry, which provided a reference for the selection of patients in the group.

  8. The main tissues and organs of the patients had good function: 1Cardiac function: no heart disease or coronary heart disease, cardiac function grade 1-2; liver function: TBILLO3ULN, aspartate 2.5ULN, alt 2.5ULN; renal function: Crusted 1.25ULN;

  9. The peripheral superficial vein of the patient is unobstructed and can meet the needs of intravenous injection;

  10. There are no other serious diseases in conflict with the programme (such as autoimmune diseases, immunodeficiency, organ transplantation);

  11. No history of other malignant tumors;

  12. Women of childbearing age must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptives during and after 3 months;

  13. The results of HIV, HBV, HCV and syphilis serological tests were negative, if one item was positive, etiological DNA or RNA test should be added, and the result should be lower than the detection sensitivity.

  14. The informed consent form must be signed before all specific research procedures begin. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form must be signed by the patient's immediate family members.

Exclusion Criteria:

  1. Acute promyelocytic leukemia (M3);

  2. Patients with cardiac insufficiency, patients with liver and renal insufficiency;

  3. Patients with other malignant tumors need to be treated;

  4. There are poorly controlled hypertension (systolic blood pressure > 160mmHg and / or diastolic blood pressure > 90mmHg) or cardiovascular and cerebrovascular diseases with clinical significance (such as activity), such as cerebrovascular accident (within 6 months before signing the informed consent), myocardial infarction (within 6 months before signing the informed consent), unstable angina pectoris, congestive heart failure, or severe arrhythmias cannot be controlled by drugs or have potential effects on research treatment.

  5. At the same time suffering from other blood system diseases (such as hemophilia, bone marrow fibrosis, etc., which researchers think are not suitable for selection)

  6. Diffuse vascular internal coagulation;

  7. Combined with uncontrollable severe infections or other serious underlying diseases;

  8. Have immune deficiency, autoimmune disease;

  9. Have severe allergic diseases;

  10. Clinical symptoms of brain dysfunction or severe mental illness can not understand or follow the research plan;

  11. Participated in other drug clinical or long-distance surgery within 21 days in the past 4 weeks;

  12. Received cell therapy in the previous month;

  13. Received hormone therapy in the previous 14 days;

  14. Known HIV positive patients or hepatitis B, C patients and syphilis patients;

  15. People who have received organ transplants (excluding stem cell transplant patients);

  16. Drug abuse, medical, psychological or social conditions that may interfere with subjects' participation in research or evaluation of research results;

  17. Pregnant or lactating women or women with the possibility of pregnancy tested positive for pregnancy before taking drugs for the first time;

  18. Unable to follow up as scheduled;

  19. The researchers believe that the subjects are not suitable to participate in this clinical study because of any clinical or laboratory abnormalities or compliance problems.

  20. Patients with previous hematological diseases such as MDS.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang China 310003
2 The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Zhejiang University
  • Hangzhou Cheetah Cell Therapeutics Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
He Huang, Clinical Professor, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05734898
Other Study ID Numbers:
  • [2023]TXB--001
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by He Huang, Clinical Professor, Zhejiang University
CAR-NK
NKG2D

Study Results

No Results Posted as of Feb 21, 2023