Actively Recruiting
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Led by Sellas Life Sciences Group · Updated on 2026-05-01
160
Participants Needed
25
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older; for specific cohorts, pediatric patients aged 12-18 years and weighing at least 40 kg are eligible
- Written informed consent obtained before any screening
- Diagnosed with relapsed or refractory AML, lymphoma, CLL, or SLL as specified per group and cohort
- Adequate liver function with bilirubin and liver enzyme levels within defined limits
- Kidney function with creatinine clearance at or above specified thresholds
- Amylase levels within normal limits
- ECOG performance status of 0 to 2
- Stable electrolytes and uric acid levels for at least 3 days before treatment
- Peripheral white blood cell counts below 50,000/µL for AML and other leukemias
- Recovery to grade 0-1 from prior anti-tumor therapy adverse events except specified exceptions
- Women of childbearing potential must use effective contraception during treatment and for specified periods after last drug administration
- Males with partners of childbearing potential must use effective contraception during treatment and for specified periods after last drug administration
- For lymphoma and CLL/SLL: specific disease presence and prior therapy requirements
- For AML cohorts: presence of specific mutations as required
- Life expectancy of at least 6 to 12 weeks depending on group
- Hematologic lab values above specified minimums for neutrophils, hemoglobin, and platelets as applicable
- Newly diagnosed AML patients must meet high-risk criteria by genetics or disease features
- First-line AML patients must have failed to achieve response after two cycles of azacitidine and venetoclax
You will not qualify if you...
- Uncontrolled hypertension or history of hypertensive crisis or encephalopathy
- Previous treatment with any CDK9 inhibitors
- Known allergy to study drugs or related agents
- Severe heart disease within past 6 months including heart failure, low ejection fraction, arrhythmia, or recent acute coronary syndromes
- Abnormal heart rhythm intervals on ECG
- Moderate or higher heart valve regurgitation
- Prior treatment with cardiotoxic agents causing heart problems
- Active hepatitis B or C infection without stable disease or proper antiviral therapy
- Known HIV infection unless on stable antiretroviral therapy with adequate immune status
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose
- Recent stroke or brain bleeding within 6 months
- Major surgery within 4 weeks before study entry
- Pregnant or breastfeeding females
- Recent stem cell transplant within 6 months, except certain autologous transplants
- Other uncontrolled illnesses that could risk patient safety
- Use of medications that prolong QT interval if not stoppable except certain antifungals
- Recent chemotherapy, immunotherapy, or radiotherapy within specified timeframes
- Bulky disease requiring cytoreductive therapy
- Symptomatic central nervous system metastases or primary lymphoma
- Use of corticosteroids above specified doses
- Baseline abnormal cardiac biomarkers
- Hypereosinophilic syndrome
- Recent pulmonary embolism or other thrombotic events posing risk
- Concurrent malignancies within past 2 to 5 years except certain treated cancers
- High risk for gastrointestinal bleeding
- For newly diagnosed AML group, prior anti-leukemic therapy except limited exceptions
- Specific genetic exclusions for AML groups
- Specific restrictions related to antifungal use and drug interactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
O'Neal Comprehensive Cancer Center, University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope - Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
3
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
4
City of Hope - Atlanta
Newnan, Georgia, United States, 30265
Actively Recruiting
5
City of Hope - Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
6
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Terminated
7
Clinical Research Alliance, Inc.
Lake Success, New York, United States, 11042
Terminated
8
New York - Presbyterian Hospital
New York, New York, United States, 10032
Terminated
9
UNC School of Medicine, Division of Hematology
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
11
Baylor Scott & White Health
Dallas, Texas, United States, 75246
Actively Recruiting
12
MD Anderson
Houston, Texas, United States, 77091
Actively Recruiting
13
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Completed
14
Anhui Provincial Hospital
Hefei, Anhui, China
Completed
15
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
Withdrawn
16
Cancer prevention and treatment center of Sun Yat sen University
Guangzhou, Guangdong, China
Completed
17
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Completed
18
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Completed
19
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Completed
20
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Completed
21
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Completed
22
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Completed
23
Linyi Cancer Hospital
Linyi, Shandong, China
Completed
24
Blood disease hospital, Chinese Academy of Medical Science
Tianjin, Tianjin Municipality, China, 300000
Completed
25
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Completed
Research Team
J
James Dean
CONTACT
C
Clinical Trials Info at Sellas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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