Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies
Trial Status: Active
This trial will evaluate Hu5F9-G4, a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. In this study, Hu5F9-G4 may be given alone or in combination with azacitidine to patients with acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS). Azacitidine is a drug used for treatment of AML or MDS in patients who are not eligible for typical chemotherapy. The major aims of the study are: to confirm the safety and tolerability of Hu5F9-G4 monotherapy in a relapsed / refractory AML and MDS population, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML and MDS; and to evaluate the efficacy of Hu5F9-G4 monotherapy in relapsed / refractory AML / MDS, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML / MDS, as measured by the objective response rate.
- Meets the criteria below for the appropriate cohort:
- 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
- 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.
- 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
- 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
City of Hope Comprehensive Cancer Center
Stanford Cancer Institute Palo Alto
University of Colorado Hospital
University of Miami Miller School of Medicine-Sylvester Cancer Center
Moffitt Cancer Center
Contact: David A. Sallman
Roswell Park Cancer Institute
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Case Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
University of Oklahoma Health Sciences Center
M D Anderson Cancer Center
Trial Phase Phase I
Trial Type Treatment
Forty Seven, Inc.
- Primary ID 5F9005
- Secondary IDs NCI-2017-02080
- Clinicaltrials.gov ID NCT03248479