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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368167
• Other study ID #: SHR2554-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Zhenyu Xiao
• Phone: 0518-82342973
• Email: zhenyu.xiao.zx7[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• SHR2554
SHR2554

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) assessed by independent review committee (IRC)	percentage of patients who achieve completes response(CR) or partial response(PR) in the study	around 1 year
Secondary	ORR assessed by investigator	percentage of patients who achieve CR or PR in the study	around 1 year
Secondary	Progression free survival	time from the first dose of SHR2554 to the first disease progression(PD) or death	around 1 year
Secondary	Time to Response	time from the first dose of SHR2554 to first CR or PR	around 4 months
Secondary	Duration of response	time from the first CR or PR to the first PD or death	around 1 year
Secondary	Overall survival	time from the fist dose of SHR2554 to death	around 5 years