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

Early Phase 1

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: haploid allogeneic NK cell therapy

• Registration Number: NCT04209712
• Lead Sponsor: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

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.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Study Start: 2020-01-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
haploid allogeneic NK cell therapy	haploid allogeneic NK cell therapy	haploid allogeneic NK cell therapy with chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Hebei Yanda Ludaopei Hospital; 🇨🇳 Langfang, Hebei, China