Actively Recruiting
A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2024-12-13
95
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
CONDITIONS
Official Title
A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Written informed consent obtained before screening
- Histologically confirmed relapsed or refractory peripheral T-cell lymphoma
- Received and failed at least 2 but no more than 5 prior lines of therapies
- At least one measurable lymphoma lesion by imaging
- Availability of fresh or archival tumor tissue at screening
- Eastern Cooperative Oncology Group performance status of 2 or less
- Adequate blood and organ function at screening
- Life expectancy of at least 12 weeks
- Recovery to grade 0-1 from prior therapy side effects except alopecia, fatigue, and less than grade 2 sensory neuropathy
- Women of childbearing potential must agree to use effective contraception during treatment and for 90 days after last dose
- Men with partners of childbearing potential must agree to use effective contraception during treatment and for 90 days after last dose
You will not qualify if you...
- Diagnosis of cutaneous T-cell lymphoma
- Symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression
- Severe hemophagocytic syndrome at screening
- Uncontrolled third space fluid buildup
- Chemotherapy, radiotherapy, or anti-tumor traditional medicines within 2 weeks before study drug
- Major surgery within 4 weeks before study drug
- Targeted therapy within 4 weeks or 5 half-lives, whichever is shorter
- Immunotherapy prior to study drug
- History of allogeneic stem cell transplant or autologous hematopoietic cell transplant within 90 days before screening
- Participation in another clinical trial within 2 weeks before study drug
- Previous exposure to any other CDK9 inhibitor
- Other malignancy within 5 years before enrollment
- Uncontrolled lung diseases including pulmonary fibrosis or interstitial lung disease
- Severe cardiovascular disease
- High risk of gastrointestinal bleeding
- Uncontrolled infections
- Ongoing corticosteroid therapy above 20 mg prednisone equivalent per day for over 14 days
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose
- Avoidance of certain citrus fruits and St. John's wort within 7 days before first dose
- Scheduled or recent major surgery
- Pregnant or breastfeeding female
- Any uncontrolled illness or condition that could endanger the patient according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jin Li
CONTACT
Y
Yuting Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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