Allogenic NK Cell Transfusion Azacitidine MDS-EB

NCT04599426 | Unknown Phase 1

• 1 other identifier: 2020.NK.MDS-EB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MDS-EB

Keywords

NK cell MDS-EB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival(OS)

  1 year

Study Arms (1)

Test Group

EXPERIMENTAL

10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen.

Biological: Allogeneic NK cell regimen group

Interventions

Allogeneic NK cell regimen group BIOLOGICAL

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 .

Test Group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
• Patients with age 15 years to 70 years.
• KPS greater than or equal to 60.
• ALT and AST are less than 3 times normal.
• Total bilirubin less than 1.5mg/dl(25.65umol/L).
• Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
• Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
• No pleural effusion in lungs.
• Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
• 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.
• KIR mismatch between patient and umbilical cord blood.
• Volunteer to participate in the trial and sign the informed consent form.

You may not qualify if:

• Malignant tumor patient.
• 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).
• Patients with HIV, HCV positive.
• Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
• Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
• Patients receiving anticoagulant therapy or with severe coagulation disorders.
• According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
• Patients with allergies or history of allergies to biological agents used in this program.
• Lactating or pregnant women.
• Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
• Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
• Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
• Patients participate in other clinical studies.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The 2nd Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

Study Officials

• Chengyun Zheng, Ph.D.

  The Second Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Chengyun Zheng, Ph.D.

CONTACT

+86-531-85875502; chengyun.zheng@ki.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (1)