Study of SLS009 for Hematologic Malignancies and High-Risk AML
This study is testing a new drug called SLS009, which is a CDK9 inhibitor (a type of medicine that blocks a specific protein involved in cancer growth). We want to see how safe and effective SLS009 is for people with blood cancers (hematologic malignancies). Some participants will receive SLS009 alone, while others will receive it in combination with venetoclax and azacitidine. We are looking for people aged 12 and older with certain types of blood cancers, including those with newly diagnosed acute myeloid leukemia (AML) or those whose AML has returned or didn't respond to previous treatments. We will measure safety by looking at side effects and how well the treatment works by checking for tumor response over about two years. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 160 participants. It is testing SLS009 alone and in combination with other drugs.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for approximately 2 years, and efficacy will be measured at 2 years.
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NCT04588922
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Recruiting
PHASE1Ages 12+InterventionalTreatmentSellas Life Sciences Group
~160 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:SLS009venetoclaxazacitidine
At a glance
Recruiting sites
10 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability: Dose Limiting Toxicities (DLTs)
Measured over 21 to 28 days
+2 more outcomes measured
Conditions
Where it's being run
26 sites across 22 statesNew York2
Texas2
Anhui2
Guangdong2
Alabama1
Arizona1
California1
Florida1
Study leadership
- Dragan Cicic, MD · STUDY_CHAIR · SELLAS Life Sciences Group, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except for patients with Gilbert's syndrome, who are included if total bilirubin is \< 3 × ULN or if direct bilirubin is \< 1.5 × ULN.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 ×ULN. 5. Measured or calculated (determined by the Cockcroft-Gault equation) serum creatinine clearance (CrCl) ≥ 60 mL/min (glomerular filtration rate can be alternative to CrCl) for adult patients or serum creatinine ≤ 1.5 x ULN; or if serum creatinine \> 1.5 x ULN, then serum creatinine clearance (CrCl) ≥ 50 mL/min (estimated by Cockcroft-Gault formula or other appropriate formula) for pediatric patients. Whether the value is calculated by equation or measured directly can be based on institutional standard practice. 6. Amylase ≤ 1.5 × ULN. 7. Eastern cooperative oncology group (ECOG) performance status 0-2. 8. The electrolytes and uric acid level need to be stable judged by investigators for at least 3 days before the first dose of GFH009 (Medical intervention is permitted).
For Lymphoma, Burkitt lymphoma, lymphoblastic lymphoma, cutaneous T-Cell lymphoma and lymphoplasmacytic lymphoma (LPL)/ Waldenstrom's macroglobulinemia (WM) will be excluded.
Patients must not be candidates for hematopoietic cell transplant (HCT) at the time of screening.
AML (only for Group 3): Patients relapsed on or refractory to venetoclax containing regimens.
CLL/SLL: Peripheral blood lymphocytosis (with no other cause), CLL present on BM aspirate, or enlarged lymph node (LN), liver or spleen.
Lymphoma (Except for other leukemias): At least one measurable or evaluable lesion as defined by the Lugano (2014) response criteria. Patients must have received at least 2 prior lines of systemic therapy.
AML, Cohort 4 (ASXL1 mutations): AML patients relapsed on and/or refractory to therapies containing venetoclax combinations and with documented ASXL1 mutation.
AML, Cohort 5 (Other than ASXL1 Myelodysplasia related AML defining somatic mutations): AML patients relapsed on and/or refractory to therapies containing venetoclax combinations and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.
Absolute neutrophil count: for lymphoma ≥ 1,000/µL without growth factor support in the 2 weeks prior to study entry; for CLL/SLL, ANC must be ≥ 500/µL if myelosuppression is known to be due to BM involvement with leukemia.
Hemoglobin ≥ 7.5 g/ dL without transfusion or erythropoietin treatment in the 2 weeks prior to study entry. Patients with BM involvement will not have the threshold of hemoglobin at screening.
Platelet count ≥ 50,000/µL without transfusion or other interventions in the 2 weeks prior to study entry.
AML patients with AML MR (AML myelodysplasia related) as defined by WHO 5th Edition (The 5th edition of the World Health Organization Classification of Hematolymphoid Tumors: Myeloid and Histiocytic/Dendritic Neoplasms). Mutations include: ASXL1, BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1, and ZRSR2. Cytogenetic changes include: complex karyotype, 5q deletion or loss of 5q due to unbalanced translocation, monosomy 7, 7q deletion, or loss of 7q due to unbalanced translocation, 11q deletion, 12p deletion or loss of 12p due to unbalanced translocation, monosomy 13 or 13q deletion, 17p deletion or loss of 17p due to unbalanced translocation, isochromosome 17q, idic(X)(q13)); and/or
AML MM (AML with myelomonocytic/ myelomonoblastic differentiation per FAB M4/M5) and/or
Mayo 2024 HR/VHR (Mayo Genetic Risk Models for Newly Diagnosed Acute Myeloid Leukemia Treated With Venetoclax + Hypomethylating Agent. High Risk is defined as ≥2 points where points are: ELN 2022 Adverse Karyotype: 1 point; IDH2wt: 1 point; TP53mut: 1 point; KRASmut: 1 point; KMT2A rearrangement: 2 points). 2. Group 5: First-line AML patients who have failed to achieve CR, CRi, or MLFS after the first 2 cycles of azacitidine/venetoclax (defined as ≥5% blasts in bone marrow or presence of circulating blasts after 2 cycles of azacitidine and venetoclax). 3. Life expectancy ≥6 weeks.
Clinically significant heart disease such as congestive heart failure requiring treatment (NYHA class III or IV), left ventricular ejection fraction (LVEF) \< 50% as determined by MUGA scan or echocardiogram (ECHO), (if only with historical occasional low LVEF but without any symptoms or relevant medical history, and the LVEF at screening is \> 50%, the subject is eligible), or clinically significant arrythmia.
History/evidence of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting).
Average QTcF ≥ 450 msec (males) or ≥ 470 msec (females) on screening ECG.
Moderate or above regurgitation on echocardiogram 5. Patients with prior treatment with cardiotoxic agents who have experienced drug induced cardiotoxicities during or after treatment, where cardiotoxic agents include but are not limited to anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin, mitoxantrone); trastuzumab and trastuzumab based ADCs; tyrosine kinase inhibitors (sunitinib, imatinib); alkylating agents (cyclophosphamide). 6. Patients who are on systemic antibiotics are eligible to participate as long as the antibiotics are not expected to have significant DDI with GFH009 (A list of approved concomitant medications will be provided to investigators. If any antibiotic is not included in the approved list, it can be discussed with the sponsor or designated CRO on a case-by-case basis). 7. Active hepatitis B or hepatitis C virus infection. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy have to be on a suppressive antiviral therapy prior to enrollment.
They have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL, and
No history of AIDS-defining opportunistic infections within the last 12 months preceding screening, and
Are on established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment. 8. Concomitant medications that are strong CYP3A4 inhibitors or strong inducers within 7 days prior to the first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pomelos, star citrus fruits or St. John's wort within 7 days of first dose. 9. Stroke or intracranial hemorrhage within 6 months. 10. Major surgery within 4 weeks prior to study entry. 11. Pregnant or breast-feeding females.
What this trial measures
- Safety and Tolerability: Dose Limiting Toxicities (DLTs)21 to 28 days
The incidence of DLTs
- Safety and Tolerability: adverse events (AEs)approximately 2 years
The incidence and severity of all AEs
- Efficacy: ORR2 years
Overall response rate is the proportion of patients showing anti-leukemic activity in response to treatment