A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects With Acute Myeloid Leukemia Who Are 60 Years or Older - The BATTLE Study

Study Overview
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Brief Summary
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This study will test the safety and effectiveness of a combination of investigational new drug called BL-8040 and atezolizumab to find out what effects, good or bad, this treatment has on medical condition. Atezolizumab is manufactured by Roche and is approved by FDA for other indications while BL-8040 is in late stages of clinical development. This is an investigational study. Approximately 60 patients will take part at multiple centers worldwide. It is an open-label study, which means that both subjects and the doctors will know which treatment you are receiving. All participants in the study will receive the investigational drug, BL-8040, both alone and in combination with atezolizumab. In other words, there will be no placebo (dummy drug). The duration of the treatment period of the study will be up to 2 years and will be followed by one year safety follow up. The study will consist of: a screening period of 21 days to allow your doctor to assess your suitability for enrollment into the study a treatment period of combination regimen of 21 day cycles for up to 2 years a follow-up period of up to 30 days after completion of combined treatment with BL-8040 + Atezolizumab an additional follow up period for up to one year after the completion of the treatment

Official Title
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A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects With Acute Myeloid Leukemia Who Are 60 Years or Older - The BATTLE Study

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: BL-8040
* Drug: Atezolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AML confirmed subjects aged ≥ 60 years who have achieved complete remission (CR or CRi) after induction/consolidation Ara-C based therapy, that have MRD positive status and are not planned for stem cell transplantation. Exclusion Criteria: Subjects diagnosed with acute promyelocytic leukemia or with extramedullary AML or subjects who have achieved CR or CRi following treatment for AML. Subjects who have received treatment with hypomethylating agents.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Treatment Single Arm<br>Combination Treatment of BL-8040 with Atezolizumab | Drug: BL-8040<br>* Subjects will receive once daily SC injections of 1.25 mg/kg of BL-8040 on the first 3 days of each cycle.<br>Drug: Atezolizumab<br>* Subjects will receive Atezolizumab 1200 mg by IV infusion on Day 2 of every cycle.<br>* Other names: Tecentriq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Free Survival | Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first | Up to 5 years |