GFH009 treatment for patients with relapsed or refractory peripheral T-cell lymphoma

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 study is testing a new treatment called GFH009 for people with relapsed or hard-to-treat peripheral T-cell lymphoma to see if it can help them.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT05934513 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label phase Ib/II study evaluates the efficacy, safety, tolerability, and pharmacokinetics of GFH009 monotherapy in patients diagnosed with relapsed or refractory peripheral T-cell lymphoma (PTCL). Participants must have previously received and failed between two to five lines of therapy and have measurable disease lesions. The study aims to provide insights into the potential of GFH009 as a treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed relapsed or refractory peripheral T-cell lymphoma who have failed multiple prior therapies.

Not a fit: Patients who have not received at least two prior lines of therapy or those with a performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with limited treatment alternatives for relapsed or refractory PTCL.

How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting relapsed or refractory lymphomas have shown promise, indicating potential for success.

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.

Where this trial is running

Guanzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guanzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jin Li

Conditions Relapsed or Refractory Peripheral T-cell Lymphoma