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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04209712
Other study ID # DS2019070101
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information

Verified date July 2020
Source Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Contact Jiang ZHU
Phone +86-15900398802
Email zhujiang@icell.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 80 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
China Hebei Yanda Ludaopei Hospital Langfang Hebei

Sponsors (2)

Lead Sponsor Collaborator
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China Hebei Yanda Ludaopei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal Residual Disease (MRD) 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. 12 months
Secondary Number of participants with adverse events Evaluation of toxicities defined as any CTCAE (v. 4.03) 12 months
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