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Follicular LymphomaPhase 2CUREFL03NCT07555470

Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma

A Phase 2 study testing Mosunetuzumab and Zeprumetostat in people with Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). 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?
Mosunetuzumab and Zeprumetostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
10 Apr 2026to 31 Dec 2029
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

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate hematologic and organ function
  • Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use highly effective contraception; male subjects must agree to use effective contraception.
  • Voluntary written informed consent
  • Cohort 1- Previously Untreated High-Risk FL：
Show all 22Show fewer
  • Histologically confirmed Grade 1-3a follicular lymphoma (FL), CD20-positive, with no evidence of histologic transformation
  • Ann Arbor Stage III/IV
  • No prior systemic therapy for FL
  • Meeting at least one of the GELF criteria for indicating treatment
  • FLIPI-1 or FLIPI-2 score of 3 to 5 (High risk)
  • Cohort 2- Previously Untreated Low-Tumor-Burden FL：
  • Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no prior systemic therapy.
  • Absence of B symptoms or severe pruritus
  • Low tumor burden (LTB) not meeting GELF criteria for treatment
  • Must have at least one measurable lesion (longest diameter >1.5 cm)
  • Patients who are suffering from the disease or prefer active management over a watch-and-wait approach
  • Cohort 3-Relapsed or Refractory FL：
  • Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no evidence of histologic transformation.、
  • Relapsed or refractory disease, having received at least 1 prior systemic therapy regimen containing an anti-CD20 antibody
  • No prior treatment with a CD20/CD3 bispecific antibody or an EZH2 inhibitor
  • Presence of at least one measurable or evaluable lesion at relapse

Who cannot join

  • Central nervous system (CNS) lymphoma, primary mediastinal lymphoma, or evidence of histologic transformation.
  • Uncontrolled cardiovascular, cerebrovascular, coagulopathy, connective tissue, or severe infectious diseases.
  • Pregnant or lactating women.
  • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) infection (RNA PCR positive).
  • Concurrent other malignancies or history of malignancies, or anti-cancer therapy (including major surgery) within the last 4 weeks.
  • Allergic reaction to the study drugs.
  • Concurrent use of strong CYP3A4 inhibitors or strong CYP3A4 inducers that cannot be avoided
  • Other medical or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shuhua Yi, Dr contact

+86-022-23909106

yishuhua@ihcams.ac.cn

China2 sites, 2 recruiting

  • Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    Yuting Yan, 13820706239, yanyuting@ihcams.ac.cn

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

    Tianjin

    Yuting Yan, Dr

    Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter, Phase 2 Study of Mosunetuzumab in Combination With Zeprumetostat for the Treatment of Follicular Lymphoma

The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). The study plans to enroll approximately 80 patients, who will be assigned to three distinct cohorts: previously untreated high-risk FL (Cohort 1), previously untreated low-tumor-burden FL (Cohort 2), and relapsed or refractory FL (Cohort 3). The study consists of a safety run-in phase, which will be initially conducted in Cohort 1 to assess the tolerability of the combination therapy, followed by an expansion phase across all three cohorts to further evaluate the clinical outcomes.

Read the detailed description

This is a prospective, open-label, multicenter, multi-cohort phase 2 study evaluating Mosunetuzumab combined with Zeprumetostat (SHR2554) in follicular lymphoma (FL). The study is conducted in two stages:

Stage 1: Safety Run-in Phase Initially, 6 participants in Cohort 1 will be enrolled to evaluate dose-limiting toxicities (DLTs) during Cycle 1 (28 days). If the safety is acceptable, the study will proceed to Stage 2.

Stage 2: Expansion Phase

Enrollment will expand to three independent cohorts:

Cohort 1: Previously untreated high-risk FL (FLIPI 3-5). Cohort 2: Previously untreated low-tumor-burden FL. Cohort 3: Relapsed or refractory FL.

Being tested
Mosunetuzumab, Zeprumetostat
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MosunetuzumabDrug

    Mosunetuzumab is administered via intravenous (IV) infusion. It is given with step-up dosing in Cycle 1: 1 mg on Day 1, 2 mg on Day 8, and 30 mg on Day 15. From Cycle 2 onwards, 30 mg is given on Day 1. Each treatment cycle is 28 days. Treatment continues for up to 8 to 12 cycles depending on the efficacy evaluation.

  • ZeprumetostatDrug

    Also called SHR2554

    Zeprumetostat is administered orally at a dose of 350 mg twice daily (BID). The treatment starts on Day 1 of Cycle 1 and continues for up to 8 or 12 cycles (each cycle is 28 days), until disease progression or unacceptable toxicity

Study groups in NCT07555470
Study groupRoleWhat they receive
Cohort 1: Previously Untreated High-Risk FLExperimentalNot described
Receives: Drug: Mosunetuzumab; Drug: Zeprumetostat
Cohort 2: Previously Untreated Low-Tumor-Burden FLExperimentalNot described
Receives: Drug: Mosunetuzumab; Drug: Zeprumetostat
Cohort 3: Relapsed or Refractory FLExperimentalNot described
Receives: Drug: Mosunetuzumab; Drug: Zeprumetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Complete Response (CR) Rate (Cohort 1 and Cohort 3)

    The best complete response (CR) rate is defined as the percentage of participants who achieve a complete response during the treatment period, as assessed by the investigator according to the Lugano 2014 classification criteria

    Measured: Up to approximately 12 months (From start of treatment until the end of up to 12 cycles of treatment)

  2. 3-Year Event-Free Survival (EFS) Rate (Cohort 2)

    Event-Free Survival (EFS) is defined as the time from the start of treatment to the first occurrence of any of the following events: progression to high-tumor-burden (HTB) based on GELF criteria, initiation of cytotoxic chemotherapy and/or radiotherapy, histologic transformation, or death from any cause.

    Measured: Up to 3 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR) (Cohorts 1, 2, and 3)

    Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) during the treatment period, assessed according to the Lugano 2014 classification

    Measured: Up to approximately 12 months (end of treatment)

  2. Rate of Progression of Disease within 24 Months (POD24) (Cohorts 1, 2, and 3)

    Percentage of participants experiencing disease progression within 24 months from the initiation of treatment

    Measured: 24 months

  3. Progression-Free Survival (PFS)

    The time from the start of treatment to disease progression or death from any cause.

    Measured: Up to approximately 5 years

  4. Overall Survival (OS)

    The time from the start of treatment to death from any cause.

    Measured: Up to approximately 5 years

  5. Change From Baseline in EORTC QLQ-C30 Score

    Evaluated using the EORTC QLQ-C30 questionnaires to assess health-related quality of life and disease-specific symptoms. Scores are transformed to a 0 to 100 scale. For global health status/quality of life and functional scales, higher scores indicate better functioning or quality of life. For symptom scales/items, higher scores indicate greater symptom burden or worse symptoms.

    Measured: Baseline up to approximately 5 years

  6. Change From Baseline in FACT-Lym LYMS Score

    The Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LYMS) score ranges from 0 to 60, with higher scores indicating better lymphoma-specific quality of life and fewer lymphoma-related symptoms. Evaluated using the FACT-Lym LYMS questionnaires to assess health-related quality of life and disease-specific symptoms.

    Measured: Baseline up to approximately 5 years

  7. Incidence and Severity of Adverse Events (AEs)

    Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0.

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start10 Apr 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555470
Sponsor's protocol ID
IIT2026013
Acronym
CUREFL03
Status last verified
Jun 2026
First submitted
13 Apr 2026
Last updated
9 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mosunetuzumab and Zeprumetostat in people with Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites 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 22 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Shuhua Yi, Dr (+86-022-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Complete Response (CR) Rate (Cohort 1 and Cohort 3) (time frame: Up to approximately 12 months (From start of treatment until the end of up to 12 cycles of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07555470.

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 9 Jun 2026.

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