Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation

Inclusion criteria

• Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
• Acute myelogenous leukemia (AML):

• Complete first remission (CR1) at high risk for relapse
• Complete second remission (CR2).
• No documented myelofibrosis at screening marrow biopsy
• Acute lymphoblastic leukemia (ALL):

• Complete first remission (CR1) at high risk for relapse
• Complete second remission (CR2).
• Other acute leukemias that are of ambiguous lineage or of other types
• Any acute leukemia with marrow aplasia or without adequate count recovery.
• Myelodysplastic Syndrome (MDS)
• Karnofsky score > 70 %.
• Calculated creatinine clearance > 60 ml/min.
• Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
• Pulmonary function (FVC, FEV1 and corrected DLCO) > 50% predicted.
• Left ventricular ejection fraction > 50%.
• Albumin > 3.0 g/dL.
• Negative antiviral serology:
• Negative human immunodeficiency virus (HIV) antibody.
• Negative human T-lymphotropic virus (HTLV)-1 and 2 antibodies.
• Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
• Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
• For female subjects of childbearing potential:

• A negative serum pregnancy test
• Willing to use contraception throughout the study period.
• Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
• Two appropriate CB units identified for the subject.
• In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
• Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
• Evidence of a signed informed written consent

Exclusion criteria

• Pregnancy or breastfeeding.
• Current active, uncontrolled bacterial, viral, or fungal infection
• Prior allogeneic or autologous HCT at any time.
• Active malignancy other than the one for which AB-110 transplant is being performed within 12 months of enrollment.
• Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
• Have evidence of recipient donor specific anti-HLA antibodies.
• Active central nervous system (CNS) disease at time of screening.
• Documented allergy to DMSO, mouse or bovine proteins, or iron.
• Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
• Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.