Clinical trial NCT04209712: Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Acute Myeloid Leukemia
Lead sponsor: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Sponsor class: INDUSTRY
Collaborators: name: Hebei Yanda Ludaopei Hospital
First posted: 2019-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: haploid allogeneic NK cell therapy with chemotherapy
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Minimal Residual Disease (MRD)
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
affiliation: Hebei Yanda Ludaopei Hospital
name: Xian Zhang
role: PRINCIPAL_INVESTIGATOR
References: