relapsed or incurable B Cell Acute Lymphoblastic Leukemia. Acute lymphoblastic leukemia, in relapse
Conditions
Interventions
Intervention group: A single infusion of Anti CD19 CAR NK cells, the patient is brought to the isolation room 4 days before receiving CAR-NK cells and gets a chemotherapeutic conditioning treatment (d
Sponsors
Omid cell and tissue processing company
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible diseases: Acute lymphocytic leukemia (ALL CD19+). Patients 3 years of age or older, and must have a life expectancy > 12 weeks. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR NK cells. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) = 2500c/ml, Platelets = 50×10^9/L, Hb = 9.0g/dL, lymphocyte (LY) = 0.7×10^9/L, LY% = 15%, Alb = 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine = 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5×upper limit of normal, serum total bilirubin = 2.0mg/dL. These tests must be conducted within 7 days prior to registration. Ability to give informed consent.
Exclusion criteria
Exclusion criteria: Pregnant or nursing women may not participate. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. The existence of unstable or active ulcers or gastrointestinal bleeding. Patients need anticoagulant therapy (such as warfarin or heparin). Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d). Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLTs). Timepoint: Daily during the first seven days after the injection and then weekly until 4 weeks. Method of measurement: History, Physical exam, and lab test.;Overall Remission Rate (ORR). Timepoint: 8 weeks after CAR-NK cells infusion. Method of measurement: Assessed using International lymphoma party (LWP) Group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using International Lymphoma Working Party (LWP) criteria.;Duration of Response (DOR). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using International Lymphoma Working Party (LWP) criteria. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMsoud Soleimani
Omid cell and tissue processing company
Outcome results
None listed