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

April 11, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital
        • Principal Investigator:
          • Yuqin Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR2554
Drug: SHR2554
SHR2554

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR2554-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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