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.