A Study of the Safety and Activity of Experimental Atezolizumab Combined With Hu5F9-G4 for Acute Myeloid Leukemia

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Refractory Acute Myeloid Leukemia, relapsed Acute Myeloid Leukemia, Acute Myeloid Leukemia, blood cancer
Type: Drug study, Phase 1
Target:
7 Participants
Investigator:
Description
The primary purpose of this study is to test the safety of experimental atezolizumab. It will be given in combination with Hu5F9- G4. We hope to understand the safety of the combination and the way your body processes these medications.

Atezolizumab in combination with Hu5F9-G4 is an experimental treatment. This means the FDA has not yet approved this combination for relapsed and/or refractory acute myeloid leukemia (R/R AML).

Atezolizumab is an antibody (a protein similar to the ones produced by your body's immune system). It blocks the programmed death−ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body's natural immune response. Tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD-L1 pathway, atezolizumab may help your immune system stop or reverse the growth of tumors.

Atezolizumab is approved in some countries for the treatment of bladder cancer and lung cancer. Hu5F9-G4 is a monoclonal antibody designed to block a protein called CD47. It is widely expressed on human cancer cells, including leukemia blasts in patients with AML. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Documented and confirmed R/R AML using the World Health Organization's classification, except acute promyelocytic leukemia
  • Adequate end-organ function
  • Negative HIV test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA <500 IU/mL at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • Willingness and ability to provide pretreatment bone marrow aspirate and biopsy and agreement to provide subsequent bone marrow aspirates and biopsies during study treatment
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
  • For women who are not postmenopausal or surgically sterile: requirement for a negative serum pregnancy test result within 28 days prior to initiation of study treatment

Exclusion criteria:

  • Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease, or requiring transplant-related immunosuppression
  • Prior solid organ transplant
  • Evidence of active central nervous system (CNS) involvement by leukemia
  • Pregnancy or lactation or intention to become pregnant during the study or within 5 months after the final dose of atezolizumab and/or Hu5F9-G4, whichever is longer
  • History of idiopathic pulmonary fibrosis, organizing pneumonitis, drug-induced pneumonitis, or idiopathic pneumonitis
  • History of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism who are on a stable dose of thyroid replacement may be eligible for this study. Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen may be eligible for this study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of the following conditions are met: (1) Rash must cover <10% of body surface area, (2) Disease is well controlled at baseline and requires only low-potency topical corticosteroids, (3) No occurrence of acute exacerbations of the underlying condition that require psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
  • Treatment with investigational therapy within 14 days prior to initiation of study drug
  • Any approved AML-related therapy within 14 days prior to enrollment. Granulocyte colony-stimulating factor to treat neutropenic fever and/or infection is permitted. Hydroxyurea may be used to control peripheral blood blast counts in response to the first dose of study treatment and during the first 4 weeks of study treatment.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be asked to take atezolizumab and Hu5F9-G4 (study treatment) until your R/R AML worsens. Your total time in the study will depend on how your R/R AML responds to treatment. This could range from 1 day to more than 12 months.
Recruitment period
From July 24, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Christina Romo
Research Topic
Conditions:
  • Acute Myeloid Leukemia