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Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

ConditionRelapsed/Refractory Peripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University

About this trial

This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18-70 years (inclusive);

Histologically confirmed peripheral T-cell lymphoma;

Disease status defined as relapsed or refractory after >=1 prior systemic treatment lines;

Have measurable lesions;

Disqualifiers

Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect within 14 days before the first dose of the study drug; received steroid hormones within 7 days prior to the first dose of study drug administration;

Underwent major surgery within 4 weeks prior to the first dose of study treatment；

Severe cardiovascular disease;

Cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-0302

    Drug

    SHR-0302 will be administered orally as tablets.

  • SHR-2554

    Drug

    SHR-2554 will be administered orally as tablets.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: SHR-0302 and SHR-2554 Treatment ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of AEs and SAEs

Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0.

Time frame
The first dose until 30 days after last dose
2

Objective response rate (ORR)

Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria.

Time frame
24 months

Secondary outcomes

1

Disease Control Rate (DCR)

Percentage of patients achieving complete response (CR) and partial response (PR) and stable disease (SD) according to Lugano 2014 criteria.

Time frame
24 months
2

Duration of Response (DoR)

Defined as the time from the date of the first CR or PR to the date of the first PD or death due to any cause, whichever occurs first.

Time frame
24 months
3

Progression-free Survival (PFS)

Defined as the time from the date of the first dose to the first documented PD or death due to any cause, whichever occurs first.

Time frame
24 months
4

Overall Survival (OS)

Defined as the duration of time from start of treatment to death from any cause.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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