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

ClinicalTrials.gov ID: NCT04588922

Public ClinicalTrials.gov record NCT04588922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04588922
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Sellas Life Sciences Group; Industry
Enrollment: 160 participants

Conditions and interventions

Conditions

Hematologic Malignancies

Interventions

Drug

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 9, 2021
Primary completion: Dec 29, 2026
Completion: Dec 30, 2027
Last update posted: Sep 2, 2026

2021 – 2027

United States locations

U.S. sites: 19
U.S. states: 14
U.S. cities: 19

Facility	City	State	ZIP	Site status
O'Neal Comprehensive Cancer Center, University of Alabama	Birmingham	Alabama	35233	Recruiting
City of Hope - Phoenix	Goodyear	Arizona	85338	Recruiting
Mayo Clinic	Phoenix	Arizona	85054	Not yet recruiting
Honor Health	Scottsdale	Arizona	85258	Recruiting
City of Hope National Medical Center	Duarte	California	91010	Recruiting
Mayo Clinic	Jacksonville	Florida	32224	Not yet recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
City of Hope - Atlanta	Newnan	Georgia	30265	Recruiting
City of Hope - Chicago	Zion	Illinois	60099	Recruiting
Ochsner Clinic Foundation	New Orleans	Louisiana	70121	Terminated
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Not yet recruiting
Atlantic Health	Morristown	New Jersey	07960	Not yet recruiting
Clinical Research Alliance, Inc.	Lake Success	New York	11042	Terminated
New York - Presbyterian Hospital	New York	New York	10032	Terminated
UNC School of Medicine, Division of Hematology	Chapel Hill	North Carolina	27599	Recruiting
Bon Secours St. Francis Cancer Center	Greenville	South Carolina	29607	Recruiting
Baylor Scott & White Health	Dallas	Texas	75246	Recruiting
MD Anderson	Houston	Texas	77091	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04588922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 2, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04588922 live on ClinicalTrials.gov.

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