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Study identifier: NCT04588922 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML

Condition: Hematologic Malignancies  ·  Sponsor: Sellas Life Sciences Group

PhasePhase 1/Phase 2
Planned participants160
Who can joinAll sexes, 12 Years to no upper limit
Healthy volunteersNo

About this study

SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.

This description comes directly from the study's public registry record.

Talk to the study team

James Dean  ·  +1 609-656-3564  ·  jdean@sellaslife.com

Clinical Trials Info at Sellas  ·  +1 646-200-5278  ·  clinicaltrialinfo@sellaslife.com

Always discuss trial participation with your own doctor first.

Locations (26)

O'Neal Comprehensive Cancer Center, University of AlabamaBirmingham, Alabama, United StatesRecruiting
City of Hope - PhoenixGoodyear, Arizona, United StatesRecruiting
City of Hope National Medical CenterDuarte, California, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
City of Hope - AtlantaNewnan, Georgia, United StatesRecruiting
City of Hope - ChicagoZion, Illinois, United StatesRecruiting
Ochsner Clinic FoundationNew Orleans, Louisiana, United StatesTerminated
Clinical Research Alliance, Inc.Lake Success, New York, United StatesTerminated
New York - Presbyterian HospitalNew York, New York, United StatesTerminated
UNC School of Medicine, Division of HematologyChapel Hill, North Carolina, United StatesRecruiting
Bon Secours St. Francis Cancer CenterGreenville, South Carolina, United StatesRecruiting
Baylor Scott & White HealthDallas, Texas, United StatesRecruiting

+ 14 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04588922