A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT ID: NCT05934513
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
95 participants
INTERVENTIONAL
2023-09-06
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GFH009
all patients will be administrated with GFH009
GFH009
patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GFH009
patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Written informed consent must be obtained prior to any screening procedures.
3. Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
4. Must have received and failed at least 2 but no more than 5 prior lines of therapies .
5. Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
6. Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
7. Eastern Cooperative Oncology Group performance status of ≤ 2.
8. Adequate haematologic and organ function at screening.
9. Life expectancy ≥ 12 week.
10. Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and \< Grade 2 sensory neuropathy.
11. For women of childbearing potential, she must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug. Men with a partner of childbearing potential, must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug
Exclusion Criteria
2. Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
3. Patients with severe hemophagocytic syndrome at screening.
4. Presence of uncontrolled third space effusion
5. Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or undergone major surgery with 4 weeks; or received targeted therapy within 4 weeks or 5 half-lives whichever is shorter; or received immunotherapy.
6. History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
7. Attend other clinical trial within 2 weeks prior to starting study drug.
8. History of previous exposure to any other CDK9 inhibitor.
9. Concurrent malignancy within 5 years prior to entry
10. Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.
11. Severe cardiovascular disease
12. Subjects with high risk of gastrointestinal hemorrhage.
13. Uncontrolled infective diseases.
14. Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day and the duration of treatment was more than 14 days.
15. 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.
16. Major surgery within 4 weeks prior to study entry or surgery is under schedule in the short run.
17. Pregnant or breast-feeding female.
18. Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genfleet Therapeutics (Shanghai) Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhiming Li
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GFH009X1201
Identifier Type: -
Identifier Source: org_study_id