Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)Phase 1/2NCT05934513
A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 1/2 study testing GFH009 in people with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- What is being tested?
- GFH009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2023to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years and ≤ 75 years.
- Written informed consent must be obtained prior to any screening procedures.
- Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
- Must have received and failed at least 2 but no more than 5 prior lines of therapies .
- Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
- Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
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- Eastern Cooperative Oncology Group performance status of ≤ 2.
- Adequate haematologic and organ function at screening.
- Life expectancy ≥ 12 week.
- Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and < Grade 2 sensory neuropathy.
- 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
Who cannot join
- Diagnosis of Cutaneous T-cell lymphoma .
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Patients with severe hemophagocytic syndrome at screening.
- Presence of uncontrolled third space effusion
- 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.
- History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
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- Attend other clinical trial within 2 weeks prior to starting study drug.
- History of previous exposure to any other CDK9 inhibitor.
- Concurrent malignancy within 5 years prior to entry
- Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.
- Severe cardiovascular disease
- Subjects with high risk of gastrointestinal hemorrhage.
- Uncontrolled infective diseases.
- 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.
- 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.
- Major surgery within 4 weeks prior to study entry or surgery is under schedule in the short run.
- Pregnant or breast-feeding female.
- Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510060
Zhiming Li, 137191891722, lzmsysu@163.com
About this study
Official title: A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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
- Being tested
- GFH009
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH009Drug
patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| GFH009 | Experimental | all patients will be administrated with GFH009 Receives: Drug: GFH009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: adverse events
Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
Phase II: Objective Response Rate
ORR(Objective Response Rate)
Measured: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start6 Sep 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)Studies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934513
- Sponsor's protocol ID
- GFH009X1201
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT05934513
- Acronym / sponsor ID
- GFH009X1201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFH009 | Experimental | Drug: GFH009all patients will be administrated with GFH009 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ≥ 18 years and ≤ 75 years.
- Written informed consent must be obtained prior to any screening procedures.
- Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
- Must have received and failed at least 2 but no more than 5 prior lines of therapies .
- Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
Key exclusion criteria (18 listed)
- Diagnosis of Cutaneous T-cell lymphoma .
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Patients with severe hemophagocytic syndrome at screening.
- Presence of uncontrolled third space effusion
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH009patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion | Drug | GFH009 |
Primary outcome
Phase Ib: adverse events
Time frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Phase II: Objective Response Rate
Time frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
ORR(Objective Response Rate)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GFH009 in people with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Li (+86 21 6882 1388, jli@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: adverse events (time frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.