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

NCT ID: NCT04209712

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

haploid allogeneic NK cell therapy

haploid allogeneic NK cell therapy with chemotherapy

Group Type: EXPERIMENTAL

haploid allogeneic NK cell therapy

Intervention Type: BIOLOGICAL

NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.

Interventions

haploid allogeneic NK cell therapy

NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: collaborator

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xian Zhang

Role: PRINCIPAL_INVESTIGATOR

Hebei Yanda Ludaopei Hospital

Locations

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang ZHU

Role: CONTACT

zhujiang@icell.com.cn

+86-15900398802

Facility Contacts

Jiang ZHU

Role: primary

zhujiang@icell.com.cn

+86-15900398802

Other Identifiers

DS2019070101

Identifier Type: -

Identifier Source: org_study_id