Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Korábbi kezelés

• 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;

Más betegség

• History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
• Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;

Laborértékek

• Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
• Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

Egyéb

• Pregnant (or lactating) women;
• Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

• 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.