Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies

Inclusion Criteria:

- Meets the criteria below for the appropriate cohort:

1. Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory
(primary refractory and/or relapsed refractory) AML or confirmed intermediate,
high, or very high risk MDS that is relapsed, refractory or intolerant to
conventional therapy

2. Treatment-naïve/ Unfit Cohorts: Previously untreated patients with histological
confirmation of AML who are ineligible for treatment with a standard cytarabine
and anthracycline induction regimen; or previously untreated patients with
intermediate, high, or very high risk MDS. Prior and concurrent therapy with
hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.

3. Rollover Cohort: Patients on active Hu5F9-G4 therapy on the Phase 1 AML
(SCI-CD47-002) trial who are deriving clinical benefit by Investigator assessment

- White blood cell (WBC) count ≤ 20 x 10E3/µL

- Adequate performance status and hematological, liver, and kidney function

Exclusion Criteria:

- Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
(with exception of Hu5F9-G4 for patients in the Rollover cohort).

- Treatment-naïve/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding
hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low
dose cytarabine.

- Acute promyelocytic leukemia.

- Known inherited or acquired bleeding disorders.

- Previous allogeneic hematopoietic stem cell transplant within 6 months prior to
enrollment, active graft versus host disease (GVHD), or requiring transplant-related
immunosuppression.

- Clinical suspicion of active central nervous system (CNS) involvement by leukemia

- Known active or chronic hepatitis B or C infection or HIV

- Pregnancy or active breastfeeding