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

Phase 2

Not yet recruiting

• Conditions: Follicular Lymphoma
• Interventions: Drug: SHR2554

• Registration Number: NCT06368167
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR2554	SHR2554	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) assessed by independent review committee (IRC)	around 1 year	percentage of patients who achieve completes response(CR) or partial response(PR) in the study

Secondary Outcome Measures

Name	Time	Method
Duration of response	around 1 year	time from the first CR or PR to the first PD or death
Progression free survival	around 1 year	time from the first dose of SHR2554 to the first disease progression(PD) or death
Overall survival	around 5 years	time from the fist dose of SHR2554 to death
ORR assessed by investigator	around 1 year	percentage of patients who achieve CR or PR in the study
Time to Response	around 4 months	time from the first dose of SHR2554 to first CR or PR

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China