Tests SHR2554 in adults with follicular lymphoma that returned or did not respond
Tests SHR2554 in adults whose follicular lymphoma returned or stopped responding.
Plain-language title generated from the registry record
Registry title: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Where in China
- Peking University Cancer HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT06368167
- Record updated
- 16 April 2024
- Original description
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular LymphomaRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Have been treated with a compound of the same machanism; 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; Have other malignancies within 5 years prior to screening Pregnant or lactating women; Known active infection; History of clinically severe cardiovascular diseases; 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; 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; Accompanied by central nervous system infiltration; The subject is taking a known medium or strong CYP inducer.