Allogenic NK Cell Transfusion Azacitidine MDS-EB

Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.

Study Overview

• Status: Not yet recruiting
• Conditions: MDS-EB
• Intervention / Treatment: Biological: Allogeneic NK cell regimen group

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Chengyun Zheng, Ph.D.; Phone Number: +86-531-85875502; Email: chengyun.zheng@ki.se

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • The 2nd Hospital of Shandong University
      • Contact: Chengyun Zheng, Ph.D.; Phone Number: +86-531-85875502; Email: chengyun.zheng@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
2. Patients with age 15 years to 70 years.
3. KPS greater than or equal to 60.
4. ALT and AST are less than 3 times normal.
5. Total bilirubin less than 1.5mg/dl(25.65umol/L).
6. Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
7. Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
8. No pleural effusion in lungs.
9. Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
10. Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.
11. KIR mismatch between patient and umbilical cord blood.
12. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Malignant tumor patient.
2. Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
3. Patients with HIV, HCV positive.
4. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
5. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
6. Patients receiving anticoagulant therapy or with severe coagulation disorders.
7. According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
8. Patients with allergies or history of allergies to biological agents used in this program.
9. Lactating or pregnant women.
10. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
11. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
12. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
13. Patients participate in other clinical studies.

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: Test Group; 10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen.	Biological: Allogeneic NK cell regimen group; 10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen. Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13，d15 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) (PR+CR)	The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	The proportion of patients with overall survival(OS).	1 year

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University
• Investigators: Study Director: Chengyun Zheng, Ph.D., The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: NK cell MDS-EB
• Other Study ID Numbers: 2020.NK.MDS-EB

Drug and device information, study documents

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