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Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209712
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Hebei Yanda Ludaopei Hospital
Information provided by (Responsible Party):
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Brief Summary:
This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: haploid allogeneic NK cell therapy Early Phase 1

Detailed Description:

Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.

NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: haploid allogeneic NK cell therapy with chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: haploid allogeneic NK cell therapy
haploid allogeneic NK cell therapy with chemotherapy
Biological: haploid allogeneic NK cell therapy
NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.




Primary Outcome Measures :
  1. Minimal Residual Disease (MRD) [ Time Frame: 12 months ]
    MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]
    Evaluation of toxicities defined as any CTCAE (v. 4.03)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with acute myeloid leukemia;
  2. MRD after 2 course of standard chemotherapy;
  3. No plan for hematopoietic stem cell transplantation;
  4. Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L;
  5. Patients have self-knowledge ability and can sign informed and voluntary consent forms;
  6. Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study.

Exclusion Criteria:

  1. Intracranial hypertension or unconsciousness;
  2. Symptomatic heart failure or severe arrhythmia;
  3. Respiratory failure;
  4. With other types of malignant tumor diseases;
  5. T lymphocytic acute leukemia;
  6. Diffuse intravascular;
  7. Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation;
  8. Serum total bilirubin >=1.5 times the normal value;
  9. Sepsis or other difficult-to-control infections;
  10. Uncontrollable diabetes;
  11. severe mental disorders;
  12. WHO physical status classification >=3;
  13. People who are allergic to Interleukin-2;
  14. Patients after organ transplant;
  15. Pregnant and lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209712


Contacts
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Contact: Jiang ZHU +86-15900398802 zhujiang@icell.com.cn

Sponsors and Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Hebei Yanda Ludaopei Hospital
Investigators
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Principal Investigator: Xian Zhang Hebei Yanda Ludaopei Hospital
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Responsible Party: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
ClinicalTrials.gov Identifier: NCT04209712    
Other Study ID Numbers: DS2019070101
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes