To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
NCT ID:
NCT06368167
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR2554
Description:
SHR2554
Arm group label:
SHR2554
Summary:
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients
with Relapsed or Refractory Follicular Lymphoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females aged ≥18 years
2. Histologically confirmed follicular lymphoma
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
4. Life expectancy ≥ 12 weeks
5. Treated with CD20 antibody, refractory to or relapse from prior anti-cancer
therapies
6. Have measurable lesions
7. The subject is willing and able to comply with the visit schedule, dosing schedule,
laboratory tests, and other clinical study procedures
Exclusion Criteria:
1. Have been treated with a compound of the same machanism;
2. Accompanied by central nervous system infiltration;
3. 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;
4. Underwent major surgery or experienced severe trauma within 4 weeks prior to the
first dose of the investigational drug
5. Known active infection
6. History of clinically severe cardiovascular diseases
7. Have other malignancies within 5 years prior to screening Pregnant or lactating
women
8. 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.
9. The subject is taking a known medium or strong CYP inducer.
10. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Investigator:
Last name:
Yuqin Song
Email:
Principal Investigator
Start date:
April 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06368167
