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CDK9 inhibitor

GFH009 for Blood Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Genfleet Therapeutics (Shanghai) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 × ULN
Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma)
Must not have
History of HIV infection or HIV positive at screening
Patients with bulky disease (≥ 10 cm) who require cytoreductive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to treat cancer, and will explore its safety and effectiveness.

Who is the study for?
This trial is for adults with certain blood cancers like AML, CLL/SLL, and lymphoma that have come back or didn't respond to treatment. They must have normal levels of bilirubin (unless they have Gilbert's syndrome), liver enzymes, amylase, lipase, and stable electrolytes. Women who can get pregnant and men with partners who can get pregnant must use two effective birth control methods during the study.
What is being tested?
The trial tests GFH009 alone in patients with relapsed/refractory acute myeloid leukemia (AML) or lymphomas. It also tests GFH009 combined with venetoclax and azacitidine in AML patients resistant to venetoclax-based treatments. The goal is to see how safe it is and if it helps against these cancers.
What are the potential side effects?
Possible side effects include reactions related to liver function changes, digestive enzyme alterations, potential heart issues due to QT interval prolongation on ECGs (a type of heart rhythm problem), as well as general risks associated with cancer drugs such as fatigue or increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver enzymes are within the required limits.
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My cancer, such as AML, CLL/SLL, or lymphoma, has returned or is not responding to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I have a large tumor (10 cm or larger) that needs treatment to reduce its size.
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I have had a heart attack or other serious heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability: Dose Limiting Toxicities (DLTs)
Safety and Tolerability: adverse events (AEs)
Secondary study objectives
Efficacy: DOR
Efficacy: ORR
Efficacy: PFS
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutationsExperimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.
Group II: Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation.Experimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented ASXL1 mutation.
Group III: Group 3 Cohort 3. 30 mg BIW in patients with r/r AML.Experimental Treatment3 Interventions
SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed).
Group IV: Group 3 Cohort 2. 60 mg QW in patients with r/r AML.Experimental Treatment3 Interventions
SLS009 (60 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed).
Group V: Group 3 Cohort 1. 45 mg QW in patients with r/r AMLExperimental Treatment3 Interventions
SLS009 (45 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed)
Group VI: Group 2. Dose escalation in patients with r/r CLL/SLL or lymphomaExperimental Treatment1 Intervention
In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China and US study sites. (Completed).
Group VII: Group 1. Dose escalation in patients with r/r AMLExperimental Treatment1 Intervention
In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2014
Completed Phase 2
~740
azacitidine
2005
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Genfleet Therapeutics (Shanghai) Inc.Lead Sponsor
6 Previous Clinical Trials
694 Total Patients Enrolled
Zhejiang Genfleet Therapeutics Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
744 Total Patients Enrolled
Sellas Life Sciences GroupLead Sponsor
8 Previous Clinical Trials
612 Total Patients Enrolled
Alan Zhu at GenFleetStudy DirectorStudy Chair
Dragan Cicic, MDStudy ChairSELLAS Life Sciences Group, Inc.
Alan ZhuStudy ChairGenFleet Therapeutics

Media Library

GFH009 (CDK9 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04588922 — Phase 1 & 2
Blood Cancers Research Study Groups: Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma, Group 1. Dose escalation in patients with r/r AML, Group 3 Cohort 1. 45 mg QW in patients with r/r AML, Group 3 Cohort 2. 60 mg QW in patients with r/r AML., Group 3 Cohort 3. 30 mg BIW in patients with r/r AML., Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation., Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations
Blood Cancers Clinical Trial 2023: GFH009 Highlights & Side Effects. Trial Name: NCT04588922 — Phase 1 & 2
GFH009 (CDK9 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588922 — Phase 1 & 2
~20 spots leftby Jun 2025