Not yet recruiting NCT06368167

A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

Phase II Interventional Follicular Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: SHR2554.
Who it may be relevant to: Registry conditions: Follicular Lymphoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma

Objective response rate (ORR) assessed by independent review committee (IRC) [Time frame: around 1 year]

Secondary outcome measures (5)

Males or females aged ≥18 years
Histologically confirmed follicular lymphoma
Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
Life expectancy ≥ 12 weeks
Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
Have measurable lesions
The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures

Have been treated with a compound of the same machanism;
Accompanied by central nervous system infiltration;
Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
Known active infection
History of clinically severe cardiovascular diseases
Have other malignancies within 5 years prior to screening Pregnant or lactating women
The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
The subject is taking a known medium or strong CYP inducer.
Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT06368167 · SHR2554-202