Health TrialsbyHealthPanel

To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

ConditionRelapsed/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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • XNW5004 tablets

    Drug

    XNW5004 will be administered orally as tablets.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: XNW5004Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) assessed by independent review committee (IRC)

Percentage of participants achieving complete response (CR) and partial response (PR) in the study.

Time frame
24 mounths

Secondary outcomes

1

ORR assessed by investigator

Percentage of participants achieving complete response (CR) and partial response (PR).

Time frame
24 mounths
2

Progression free survival

time from the first dose of to the first disease progression(PD) or death

Time frame
24 mounths
3

Time to Response

time from the first dose of XNW5004 to first CR or PR

Time frame
around 4 months
4

Duration of response

time from the first CR or PR to the first PD or death

Time frame
24 mounths

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evopoint Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: