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Trial Title:
A Study of GFH009 Monotherapy in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT ID:
NCT05934513
Condition:
Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GFH009
Description:
patients are planned to be administrated with GFH009 every week in a 21 days cycle,
intravenous infusion
Arm group label:
GFH009
Summary:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 years and ≤ 75 years.
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:
1. Diagnosis of Cutaneous T-cell lymphoma .
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li
Phone:
137191891722
Email:
lzmsysu@163.com
Start date:
September 6, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Zhejiang Genfleet Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Genfleet Therapeutics (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934513
