Status:
NOT_YET_RECRUITING
Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
Lead Sponsor:
Zhejiang University
Conditions:
Hematological Malignancies
Eligibility:
All Genders
15-60 years
Phase:
EARLY_PHASE1
Brief Summary
Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies
Detailed Description
This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
- Relapsed or refractory AML (meeting one of the following conditions):
- CR not achieved after standardized chemotherapy;
- CR achieved following the first induction, but CR duration is less than 12 months;
- Ineffectively after first or multiple remedial treatments;
- 2 or more relapses;
- The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- Estimated survival time ≥ 3 months;
- ECOG performance status 0 to 2;
- Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
Exclusion
- History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
- Previously treated with any CAR-T cell product or other genetically- modified T cell therapies;
- Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04662788
Start Date
January 1 2021
End Date
January 1 2027
Last Update
December 10 2020
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China