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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Biological: haploid allogeneic NK cell therapy

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China, 065201
      • Recruiting
      • Hebei Yanda Ludaopei Hospital
      • Contact: Jiang ZHU; Phone Number: +86-15900398802; Email: zhujiang@icell.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: haploid allogeneic NK cell therapy; haploid allogeneic NK cell therapy with chemotherapy	Biological: haploid allogeneic NK cell therapy; NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Residual Disease (MRD)	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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Collaborators: Hebei Yanda Ludaopei Hospital
• Investigators: Principal Investigator: Xian Zhang, Hebei Yanda Ludaopei Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm, Residual
• Other Study ID Numbers: DS2019070101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No