Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

Inclusion Criteria (DONOR):

- Age 18 to 70 years of age.

- ECOG performance status of 0 or 1.

- PART 1: Donor must be a 5/6 or 6/6 HLA-matched sibling willing to donate PBSC for
transplant.

- PART 2: Donor must be a 5/6 or 6/6 HLA-matched sibling or 3/6 or 4/6 HLA
haploidentical donor willing to donate PBSC for transplant. Haploidentical donors will
be allowed to participate upon investigator decision and based on the data reached
from 5/6 or 6/6 HLA matched transplant done during Part 1 of the study.

- Adequate organ function defined by:

- serum creatinine within normal limits or a minimum creatinine clearance (CrCl)
value of ≥ 60 ml/min calculated using the Modification of Diet in Renal Disease
(MDRD) Study equation

- AST, ALT and total bilirubin ≤ 2x institutional upper limit of normal.

- Women of childbearing potential and men must agree to use adequate contraception with
two different forms, including one barrier method, during participation in the study
and for 2 weeks following dosing with BL-8040. Abstinence is acceptable if this is the
established and preferred contraception for the subject.

- Female subjects must have a negative urine or serum pregnancy test within 10 days
prior to taking study medication if of childbearing potential or must be of
non-childbearing potential. If the urine test is positive or cannot be confirmed as
negative, a serum pregnancy test will be required. The serum pregnancy test must be
negative for the subject to be eligible. Non-childbearing potential is defined as:

-≥ 45 years of age and has not had menses for > 2 years

- Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value in
the postmenopausal range upon pretrial (screening) evaluation

- Post-hysterectomy, oophorectomy, or tubal ligation.

- Able and willing to comply with the requirements of the protocol.

- Able to understand and willing to sign an IRB-approved written informed consent
document.

Inclusion Criteria (RECIPIENT):

- Age 18 to 75 years

- ECOG performance status of 0-2 (inclusive)

- One of the following diagnoses:

- Acute myelogenous leukemia (AML) in 1st or subsequent remission

- Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission

- Chronic myelogenous leukemia (CML) in chronic or accelerated phase

- Non-Hodgkin lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete
remission, partial remission

- Chronic lymphocytic leukemia (CLL)

- Multiple myeloma (MM)

- Myelodysplastic syndrome (MDS)

- Myeloproliferative neoplasm (MPN) excluding primary or secondary myelofibrosis

- Adequate organ function defined by:

- a creatinine clearance (CrCl) value of ≥ 60 ml/min by MDRD study equation

- AST, ALT and a total bilirubin ≤ 2x institutional upper limit of normal.

- Adequate cardiac function with a left ventricular ejection fraction ≥ 40%.

- Adequate pulmonary function defined as NO severe or symptomatic restrictive or
obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50%
of predicted and a DLCO ≥ 40% of predicted, corrected for hemoglobin.

- Female subjects must have a negative urine or serum pregnancy test if of childbearing
potential or be of non-childbearing potential. If the urine test is positive or cannot
be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy
test must be negative for the subject to be eligible. Non-childbearing potential is
defined as:

*≥ 45 years of age and has not had menses for > 2 years

- Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value
in the postmenopausal range upon pretrial (screening) evaluation

- Post-hysterectomy, oophorectomy, or tubal ligation.

- Able to understand and willing to sign an IRB-approved written informed consent
document.

Exclusion Criteria (DONOR):

- Received any investigational agent within 30 days and/or 5 half-lives (of the other
investigational agent), whichever is longer, of receiving BL-8040.

- Active HIV or hepatitis B or C infection

- Pregnant or breastfeeding.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Known allergy or hypersensitivity to any of the test compounds, materials, or
contraindication to test products.

- Any malignancies in the 2 years prior to baseline, excluding: basal cell carcinoma, in
situ malignancy, low-risk prostate cancer, cervix cancer after curative therapy.

- A comorbid condition which, in the view of the investigators, renders the subject at
high risk from treatment complications.

Exclusion Criteria (RECIPIENT):

- Recipient must not have received any investigational drug within 30 days of starting
conditioning treatment.

- Pregnant or breastfeeding.

- Active HIV or hepatitis B or C infection.

- Any medical condition which, in the opinion of the clinical investigator, would
interfere with the evaluation of the patient. Subjects with a clinically significant
or unstable medical or surgical condition or any other condition that cannot be
well-controlled by the allowed medications permitted in the study protocol that would
preclude safe and complete study participation, as determined by medical history,
physical examinations, ECG, laboratory tests, or chest-X-ray and according to the
investigator's judgment.