Relapsed/Refractory Follicular LymphomaPhase 2NCT07031700
A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
A Phase 2 study testing Mosunetuzumab and Tislelizumab in people with Relapsed/Refractory Follicular Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Follicular Lymphoma
- What is being tested?
- Mosunetuzumab and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jul 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
- Signed written informed consent.
- Age ≥18 years.
- Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
- Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
- ECOG performance status 0-1.
- Expected survival ≥12 weeks.
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- Measurable disease (longest diameter >1.5 cm).
- Adequate organ function:
- Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.
- Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.
- Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
- Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.
Who cannot join
- Inability to comply with study hospitalization and restrictions.
- Active infections (including tuberculosis) or immunocompromised status.
- Prior history of severe hypersensitivity to similar agents.
- CNS involvement of lymphoma.
- Pregnant or breastfeeding women.
- Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
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- Receipt of live attenuated vaccines within 4 weeks before enrollment.
- Use of systemic immunosuppressants within 2 weeks prior to first dose.
- History of drug or alcohol abuse in the past 12 months.
- Any condition deemed inappropriate for study participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)
This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).
Read the detailed description
The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Being tested
- Mosunetuzumab, Tislelizumab
- 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
- Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg
- Cycles 2-8: 30 mg every 3 weeks
- Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.
TislelizumabDrug
- Cycles 2-8: 200 mg IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| combination therapy of Mosunetuzumab and Tislelizumab | Experimental | Not described Receives: Drug: Mosunetuzumab; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
best of complete response rate (CR)
To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
Measured: up to the end of 8/17 cycles of treatment(each cycle 21 days)
Secondary outcomes (4)
Overall Response Rate (ORR)
Objective Response Rate is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment with Mosunetuzumab and Tislelizumab, as assessed according to Lugano 2014 criteria.
Measured: up to the end of 8/17 cycles of treatment(each cycle 21 days)
Duration of Response (DoR)
Duration of Response is defined as the time from the first documentation of objective response (CR or PR) to the first documentation of disease progression or death from any cause, whichever occurs first. Response will be assessed per Lugano 2014 criteria.
Measured: up to 2 years
Progression-free survival (PFS)
Progression-Free Survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.
Measured: Assessed every 3 months during follow-up, up to 2 years
OS
Overall Survival is defined as the time from initiation of study treatment to death from any cause.
Measured: Assessed every 3 months during follow-up, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031700
- Sponsor's protocol ID
- FL-RR-MOS01
- Status last verified
- Jun 2025
- First submitted
- 11 Mar 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)
- ClinicalTrials.gov ID
- NCT07031700
- Acronym / sponsor ID
- FL-RR-MOS01
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jun 2025 (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.
This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).
Detailed description
The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination therapy of Mosunetuzumab and Tislelizumab | Experimental | Drug: Mosunetuzumab, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent.
- Age ≥18 years.
- Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
- Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
- ECOG performance status 0-1.
Key exclusion criteria (10 listed)
- Inability to comply with study hospitalization and restrictions.
- Active infections (including tuberculosis) or immunocompromised status.
- Prior history of severe hypersensitivity to similar agents.
- CNS involvement of lymphoma.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Mosunetuzumab* Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg * Cycles 2-8: 30 mg every 3 weeks * Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs. | Drug | combination therapy of Mosunetuzumab and Tislelizumab |
| Tislelizumab- Cycles 2-8: 200 mg IV every 3 weeks | Drug | combination therapy of Mosunetuzumab and Tislelizumab |
Primary outcome
best of complete response rate (CR)
Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)
To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)
Duration of Response (DoR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: Assessed every 3 months during follow-up, up to 2 years
OS
Time frame: Assessed every 3 months during follow-up, up to 2 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 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosunetuzumab and Tislelizumab in people with Relapsed/Refractory Follicular Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 12 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Huilai Zhang (+86-18622221228, huilaizhangtz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best of complete response rate (CR) (time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)). 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 22 Jun 2025.