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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04209712

Enrollment

Registered

2019-12-24

Start date

2020-01-01

Completion date

2021-12-31

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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.

Interventions

BIOLOGICALhaploid allogeneic NK cell therapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

haploid allogeneic NK cell therapy with chemotherapy

Eligibility

Sex/Gender

ALL

Age

1 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Minimal Residual Disease (MRD)	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

Measure	Time frame	Description
Number of participants with adverse events	12 months	Evaluation of toxicities defined as any CTCAE (v. 4.03)

Countries

China

Contacts

Primary ContactJiang ZHU

zhujiang@icell.com.cn+86-15900398802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026