Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation

Study Groups:

If participant is found to be eligible to take part in this study and participant agrees,
participant will be assigned to a study group based on when participant joined this study.

In Part 1 of the study, 3 dose levels of CYT107 will be tested in this study. Up to 3
participants will be enrolled in each dose level. The first group of participants will
receive the lowest dose level. The next group will receive a higher dose than the first
group, if no intolerable side effects were seen. The third group will receive an even higher
dose than the second, if no intolerable side effects were seen. Based on the results seen, 1
of the 3 doses will be selected as the recommended dose.

In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at
the recommended dose found in Part 1.

Study Drug Administration:

Participant will be given one injection of CYT107 directly into the muscle 1 time each week
for 3 weeks. If the doctor thinks it is needed, participant may be able to receive CYT107 as
an injection under the skin instead of the muscle.

Participant will be given standard drugs to help decrease the risk of side effects.
Participant may ask the study staff for information about how the drugs are given and their
risks.

Length of Study Participation:

Participant may receive up to 3 injections of CYT107. Participant will no longer be able to
take the study drug if the disease gets worse, if intolerable side effects occur, or if
participant is unable to follow study directions.

Participation in this study will be over about 1 year after the last injection.

Study Visits:

One (1) time each week during Weeks 1-3:

- Participant will have a physical exam.

- Blood (about 4 teaspoons) will be drawn for routine tests.

Before each dose of CYT107 and then about 21, 28, and 100 days after the first injection,
blood (about 1 tablespoon each time) will be drawn to check your immune system function, to
check for infections, and to check the effects of CYT107 on participant's body.

One (1) time each week for about 6 months, blood (about 4 teaspoons) will be drawn to check
for CMV. Part of the blood may be used to check for EBV. If participant has symptoms of BK
infection during the study, blood (about 1 teaspoon) and urine will also be collected to
check for the BK virus.

Pharmacokinetic (PK) and Research Testing:

Blood (about 1 tablespoon each time) will be drawn for PK testing before participant's first
CYT107 injection and then 3 more times over the 24 hours after participant's first injection.
Blood will also be drawn after participant's last CYT107 injection. PK testing measures the
amount of study drug in the body at different time points.

Before the first CYT107 injection and on Day 42, blood (about 1 teaspoon each time) will be
drawn to test for anti-CYT107 antibodies. Antibodies are created by the immune system and may
attack foreign cells or substances, such as CYT107. If the test on Day 42 is positive, blood
(about 1 teaspoon) will be drawn on Day 100 to check for CYT107 antibodies. These blood
samples will be sent to the study supporter, Revimmune. After the samples are used for this
antibody testing, the samples will be destroyed.

Follow-Up:

After participant's last dose of CYT107, participant will continue to have follow-up visits
as part of participant's standard care (visits participant would have even if participant was
not taking part in this study) for up to 1 year after participant's last dose. Information
from these follow-up visits, such as results of any standard of care testing, will be
collected.

Inclusion Criteria:

1. Patient 18 years old or older.

2. Patient post a cord blood transplant (CBT) with documented absolute neutrophil
engraftment and no evidence of GVHD or no history of acute or chronic GVHD requiring
systemic steroids.

3. Patients with documented engraftment but require granulocyte colony-stimulating factor
(G-CSF) for myelosuppressive antibiotics or antiviral medications are eligible.

4. Karnofsky performance status (KPS) > 60%.

5. Adequate organ function: Pulmonary: Absence of dyspnea or hypoxia (< 90% of saturation
by pulse oximetry on room air).

6. Hepatic: Bilirubin < 1.5 X ULN.

7. Renal: Calculated Creatinine clearance > 60 mL/min/1.73 m2.

8. Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid
leukemia or myeloproliferative disease.

Exclusion Criteria:

1. Pregnant or nursing.

2. History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, Acute
Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia) or acute biphenotypic
leukemia.

3. History of EBV associated lymphoproliferation.

4. Active uncontrolled viral, bacterial or fungal infection.

5. Documented human immunodeficiency virus (HIV)-1 or -2, hepatitis B virus (HBV), or
hepatitis C virus (HCV) infection at any time before or after transplant. (a positive
hepatitis B serology indicative of a previous immunization is not an exclusion
criteria).

6. EBV viremia equal to or greater than 500 copies EBV DNA/mL of blood by quantitative
PCR.

7. History of autoimmune disease.

8. Receiving systemic corticosteroid therapy.

9. Receiving concurrent treatment with another investigational drug and/or biological
agent.

10. Receiving anticoagulant therapy.

11. Uncontrolled hypertension.

12. QTc prolongation (QTc > 470 ms) or prior history of significant arrhythmia or ECG
abnormalities.

13. Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements.

14. Any past or current psychiatric illness that, in the opinion of the investigator,
would interfere with adherence to study requirements or the ability and willingness to
give written informed consent.