To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEvopoint Biosciences Inc.
About this trial
This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects.
Eligibility criteria
Qualifiers
Aged 18-70 years (inclusive)，gender not limited.
Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.
Disease status defined as relapsed or refractory after >=2 prior systemic treatment lines, including at least one new drug; subjects with CD30 positive ALCL requires prior treatment with Brentuximab vedotin.
Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.
Disqualifiers
Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s);
Subjects with known hypersensitivity to the study drug or its active ingredients or excipients.
Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug.
Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.
Trial design
Treatments tested in this trial
- XNW5004 tablets
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov