search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
haploid allogeneic NK cell therapy
Sponsored by
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

1 Year - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hebei Yanda Ludaopei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

haploid allogeneic NK cell therapy

Arm Description

haploid allogeneic NK cell therapy with chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with adverse events
Evaluation of toxicities defined as any CTCAE (v. 4.03)

Full Information

First Posted
December 20, 2019
Last Updated
July 27, 2020
Sponsor
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Collaborators
Hebei Yanda Ludaopei Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04209712
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Collaborators
Hebei Yanda Ludaopei Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
haploid allogeneic NK cell therapy with chemotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
haploid allogeneic NK cell therapy
Arm Type
Experimental
Arm Description
haploid allogeneic NK cell therapy with chemotherapy
Intervention Type
Biological
Intervention Name(s)
haploid allogeneic NK cell therapy
Intervention Description
NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.
Primary Outcome Measure Information:
Title
Minimal Residual Disease (MRD)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Evaluation of toxicities defined as any CTCAE (v. 4.03)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with acute myeloid leukemia; MRD after 2 course of standard chemotherapy; No plan for hematopoietic stem cell transplantation; Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L; Patients have self-knowledge ability and can sign informed and voluntary consent forms; Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study. Exclusion Criteria: Intracranial hypertension or unconsciousness; Symptomatic heart failure or severe arrhythmia; Respiratory failure; With other types of malignant tumor diseases; T lymphocytic acute leukemia; Diffuse intravascular; Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation; Serum total bilirubin >=1.5 times the normal value; Sepsis or other difficult-to-control infections; Uncontrollable diabetes; severe mental disorders; WHO physical status classification >=3; People who are allergic to Interleukin-2; Patients after organ transplant; Pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang ZHU
Phone
+86-15900398802
Email
zhujiang@icell.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian Zhang
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065201
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang ZHU
Phone
+86-15900398802
Email
zhujiang@icell.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs