Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej (dla niektórych grup także dzieci od 12 lat i starsze)
- •Rozpoznana białaczka (AML) lub chłoniak, które nie odpowiadają na poprzednie leczenie
- •Podpisana zgoda na udział w badaniu
- •Prawidłowe funkcjonowanie wątroby (test krwi)
- •Prawidłowe funkcjonowanie nerek (test krwi)
- •Ogólny stan zdrowia pozwalający na leczenie (ocena lekarza)
- •Stabilne poziomy elektrolitów i kwasu moczowego przez co najmniej 3 dni przed rozpoczęciem leczenia
- •Liczba białych krwinek poniżej 50 000/µL
Simplified criteria — AI translation
Trial details
- Minimum age
- 12 Years
- Last updated (source)
- July 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (26)
O'Neal Comprehensive Cancer Center, University of Alabama
Birmingham, United States
City of Hope - Phoenix
Goodyear, United States
City of Hope National Medical Center
Duarte, United States
Moffitt Cancer Center
Tampa, United States
City of Hope - Atlanta
Newnan, United States
City of Hope - Chicago
Zion, United States
Ochsner Clinic Foundation
New Orleans, United States
Clinical Research Alliance, Inc.
Lake Success, United States
New York - Presbyterian Hospital
New York, United States
UNC School of Medicine, Division of Hematology
Chapel Hill, United States
Bon Secours St. Francis Cancer Center
Greenville, United States
Baylor Scott & White Health
Dallas, United States
MD Anderson
Houston, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Anhui Provincial Hospital
Hefei, China
Affiliated Cancer Hospital of Chongqing University
Chongqing, China
Cancer prevention and treatment center of Sun Yat sen University
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Affiliated Hospital of Hebei University
Baoding, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
The First Affiliated Hospital Of Nanchang University
Nanchang, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, China
Linyi Cancer Hospital
Linyi, China
Blood disease hospital, Chinese Academy of Medical Science
Tianjin, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, China
Trial contact
James Dean
Clinical Trials Info at Sellas
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
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