Follicular LymphomaPhase 2NCT06368167
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 2 study testing SHR2554 in people with Follicular Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- SHR2554
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song
About this study
Official title: 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
- Conditions
- Follicular Lymphoma
- Being tested
- SHR2554
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554Drug
SHR2554
| Study group | Role | What they receive |
|---|---|---|
| SHR2554 | Experimental | Not described Receives: Drug: SHR2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: around 1 year
Secondary outcomes (5)
ORR assessed by investigator
percentage of patients who achieve CR or PR in the study
Measured: around 1 year
Progression free survival
time from the first dose of SHR2554 to the first disease progression(PD) or death
Measured: around 1 year
Time to Response
time from the first dose of SHR2554 to first CR or PR
Measured: around 4 months
Duration of response
time from the first CR or PR to the first PD or death
Measured: around 1 year
Overall survival
time from the fist dose of SHR2554 to death
Measured: around 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368167
- Sponsor's protocol ID
- SHR2554-202
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT06368167
- Acronym / sponsor ID
- SHR2554-202
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR2554 | Experimental | Drug: SHR2554 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR2554SHR2554 | Drug | SHR2554 |
Primary outcome
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
5 secondary outcomes
ORR assessed by investigator
Time frame: around 1 year
Progression free survival
Time frame: around 1 year
Time to Response
Time frame: around 4 months
Duration of response
Time frame: around 1 year
Overall survival
Time frame: around 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR2554 in people with Follicular Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Xiao (0518-82342973, zhenyu.xiao.zx7@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) assessed by independent review committee (IRC) (time frame: around 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.