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):

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

  1. Complete first remission (CR1) at high risk for relapse
  2. 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:

  1. A negative serum pregnancy test
  2. 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.