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

Shanghai iCELL Biotechnology

Status and phase: Unknown; Early Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Biological: haploid allogeneic NK cell therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04209712

DS2019070101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 1 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

haploid allogeneic NK cell therapy

Experimental group

Description:

haploid allogeneic NK cell therapy with chemotherapy

Treatment:

Biological: haploid allogeneic NK cell therapy