NCT04599426UnknownPhase 1
Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB
The Second Hospital of Shandong University1 site in 1 country10 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR) (PR+CR)
Study Overview
Brief Summary
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 m
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Objective Response Rate (ORR) (PR+CR)
Time Frame: 3 months
The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes
Secondary Outcomes
- Overall survival(OS)(1 year)
Investigators
Study Sites (1)
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