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NCT Number: NCT06368167

A Phase II Study 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location contact

Yuqin Song

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Have been treated with a compound of the same machanism;
  • Accompanied by central nervous system infiltration;
  • 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
  • Known active infection
  • History of clinically severe cardiovascular diseases
  • Have other malignancies within 5 years prior to screening Pregnant or lactating women
  • 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.
  • The subject is taking a known medium or strong CYP inducer.
  • 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

Treatment and study plan

SHR2554

Drug

SHR2554

Primary outcomes

  1. 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

Secondary outcomes

  1. ORR assessed by investigator

    Time frame: around 1 year

    percentage of patients who achieve CR or PR in the study

  2. Progression free survival

    Time frame: around 1 year

    time from the first dose of SHR2554 to the first disease progression(PD) or death

  3. Time to Response

    Time frame: around 4 months

    time from the first dose of SHR2554 to first CR or PR

  4. Duration of response

    Time frame: around 1 year

    time from the first CR or PR to the first PD or death

  5. Overall survival

    Time frame: around 5 years

    time from the fist dose of SHR2554 to death

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenyu Xiao

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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