Follicular LymphomaPhase 2SUNFLOWNCT07191249
Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .
A Phase 2 study testing Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells. in people with Follicular Lymphoma, run by Tel-Aviv Sourasky Medical Center at 4 sites in Israel.
Trial summary
This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria. 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 is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesIsrael
- Study dates
- 5 Jan 2026to 1 Mar 2030
- 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
- at least 18 years old
- Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)
- Low tumor burden by GELF criteria
- No prior therapy except surgery or radiotherapy for disease that was previously localized
- Ann Arbor Stage III or IV disease
- Bi-dimensionally measurable FDG-avid disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan and/or clinical examination
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- Adequate hematologic function defined as follows without growth factors or blood product transfusion within 14 days of first dose of study drug administration:
- Hemoglobin, without transfusion, 9 g/dL
- ANC 1.0 109/L
- Platelet count 75 109/L;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patient can understand and sign the Informed Consent Form (ICF), can communicate with the Investigator, can understand and comply with the requirements of the protocol
Who cannot join
- 1. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count > 200 cell/mcl
- 2. Any of the following laboratory abnormalities:
- Total Bilirubin or GGT or AST or ALT > 3 X ULN.
- Creatinine Clearance calculated by Cockcroft and Gault Formula < 40 ml/min
- Presence or history of CNS involvement by lymphoma
- 4. Prior history of malignancies other than Lymphoma (except for Basal Cell or Squamous Cell Carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 2 years
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- Contraindication to use Mosunetuzumabor known sensitivity or allergy
- Pregnant or lactating females
- 7. Female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 3 months thereafter
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Shimrit Ringelstein, Dr, S_ringelstein@rambam.health.gov.il
Dorin Carmel, d_carmel@rambam.health.gov.il
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Sara Matarasso, Dr, sarahmat@szmc.org.il
Tehilla Babila, tehilabab@szmc.org.il
- Recruiting
The Hadassah University Hospital-Ein Kerem
Jerusalem
Shlomzion Aumann, Dr., Aumann@hadassah.org.il
Yuval Mor-Elzas, mormoy@hadassah.org.il
- Recruiting
Tel Aviv Sourasky Medical Center (TASMC) - Ichilov
Tel Aviv
Irit Avivi, Prof, iritavi@tlvmc.gov.il
Nofar Shmuel, nofarshm@tlvmc.gov.il
About this study
Official title: A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL).
This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.
Read the detailed description
Eligible patients will undergo screening and, upon signing an Informed Consent Form, will receive their first dose of SC Mosunetuzumab.
Mosunetuzumab is administered via SC injection without the need for mandatory hospitalization. The first cycle lasts 21 days, followed by subsequent 21-day cycles. In Cycle 1, Mosunetuzumab is given on Day 1 (5 mg), Day 8 (45 mg), and Day 15 (45 mg). From Cycle 2 onward, a single 45 mg dose is administered on Day 1 of each cycle. Treatment continues for up to 8 cycles (approximately 6 months).
Patients will be monitored for disease status according to standard clinical practice. After completing active treatment, they will enter a post-treatment follow-up phase.
Premedication with dexamethasone (20 mg) is mandatory in Cycle 1 and optional in later cycles. Acetaminophen and diphenhydramine may also be administered.
All patients will continue study treatment as per the Schedule of Activities or until premature discontinuation. After treatment discontinuation, disease status assessments will occur approximately every 3 months for up to 24 months. During post-treatment follow-up, PET-CT scans for disease evaluation will be performed every 6 months, as applicable. Patients not under active follow-up will be contacted annually to collect data on disease status and survival.
Throughout the trial, the following data will be collected (as applicable): demographics and baseline characteristics (including sex, age, race, height, and weight), medical history, details of initial diagnosis and treatment history, concomitant medications, adverse events (AEs), serious adverse events (SAEs), disease response, and survival status.
- Conditions
- Follicular Lymphoma
- Being tested
- Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.
- Keywords
- Fullicular Lymphoma-Previously Untreated Low Tumor Burden, Mosunetuzumab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.Drug
In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles.
| Study group | Role | What they receive |
|---|---|---|
| Patients with follicular lymphoma with low tumor burden who have not been previously treated | Experimental | In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles. Receives: Drug: Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
ORR is defined as the proportion of patients who achieved Complete Response or Partial Response determined by Lugano 2014 criteria as assessed by investigators at 6 months after initiation of treatment and prior to the initiation of any subsequent anti-lymphoma therapy. Patients without post-baseline disease assessments will be considered non-responders.
Measured: 6 months
Secondary outcomes (8)
Progression Free Survival -PFS
PFS is defined as the time in months from the first dose of study drug to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving patients without disease progression will be censored at the time of the last adequate disease assessment. Surviving subjects without post-baseline disease assessment will be censored at the date of first dose of study drug.
Measured: up to 24 months after last treatment dose
Duration of response -DOR
DOR is defined for patients who achieved Complete Response (CR) or Partial Response (PR) ('responders'), as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment
Measured: up to 24 months after last treatment dose
Complete Response Rate - CRR - Lymphoma (FACT-Lym) subscale.
CRR is defined as the proportion of patients who achieved Complete Response, determined by Lugano 2014 criteria as assessed by the investigator. All responses of Complete Response after initiation of subsequent anti-lymphoma therapy will be excluded. Subjects without post-baseline disease assessments will be considered as not achieving Complete Response.
Measured: up to 24 months after last treatment dose
Duration of Complete Response -DOCR
DOCR is defined for patients who achieved Complete Response, as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment.
Measured: up to 24 months after last treatment dose
Time to Next Treatment -TTNT
TTNT is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified anti-lymphoma therapy or death due to disease progression. Surviving patients who were reported as not having started new non-protocol-specified anti-lymphoma therapy will be censored at the last known alive date to be free of non-protocol-specified anti-lymphoma therapy. Surviving patients without any post-baseline visit will be censored at the date of the first dose of study drug
Measured: up to 24 months after last treatment dose
Overall Survival -OS
OS is defined as the time in months from the first dose of study drug to death from any cause. Patients who are still alive at the end of the study or at the time of the analyses (12 and 24 months after the first dose of study drug) will be censored at the last known alive date
Measured: up to 24 months after last treatment dose
Statistical Analysis for Safety
Incidence of adverse events (AEs) and abnormal laboratory test results - including all AEs, treatment-emergent AEs (TEAEs), Adverse drug reactions (ADRs), SAEs, AEs leading to discontinuation, and AEs leading to death.
Measured: from first dose through 90 days after administration of last dose
Health related quality of life
Health-related quality of life will be assessed using the FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) questionnaire.
Measured: whole treatment period- 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start5 Jan 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Mar 2030 (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 Tel-Aviv Sourasky Medical CenterThe 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
- Model description
- This is a Phase 2, single-arm, open-label study evaluating the efficacy and safety of subcutaneous Mosunetuzumab in patients with low-tumor-burden follicular lymphoma. All participants will receive the same intervention product without randomization.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Irit Avivi, Prof, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191249
- Sponsor's protocol ID
- 0691-24-TLV
- Acronym
- SUNFLOW
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL).
- ClinicalTrials.gov ID
- NCT07191249
- Acronym / sponsor ID
- SUNFLOW / 0691-24-TLV
- Conditions
- Follicular Lymphoma
- Keywords
- Fullicular Lymphoma-Previously Untreated Low Tumor Burden, Mosunetuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 24 Sep 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 multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.
Detailed description
Eligible patients will undergo screening and, upon signing an Informed Consent Form, will receive their first dose of SC Mosunetuzumab.
Mosunetuzumab is administered via SC injection without the need for mandatory hospitalization. The first cycle lasts 21 days, followed by subsequent 21-day cycles. In Cycle 1, Mosunetuzumab is given on Day 1 (5 mg), Day 8 (45 mg), and Day 15 (45 mg). From Cycle 2 onward, a single 45 mg dose is administered on Day 1 of each cycle. Treatment continues for up to 8 cycles (approximately 6 months).
Patients will be monitored for disease status according to standard clinical practice. After completing active treatment, they will enter a post-treatment follow-up phase.
Premedication with dexamethasone (20 mg) is mandatory in Cycle 1 and optional in later cycles. Acetaminophen and diphenhydramine may also be administered.
All patients will continue study treatment as per the Schedule of Activities or until premature discontinuation. After treatment discontinuation, disease status assessments will occur approximately every 3 months for up to 24 months. During post-treatment follow-up, PET-CT scans for disease evaluation will be performed every 6 months, as applicable. Patients not under active follow-up will be contacted annually to collect data on disease status and survival.
Throughout the trial, the following data will be collected (as applicable): demographics and baseline characteristics (including sex, age, race, height, and weight), medical history, details of initial diagnosis and treatment history, concomitant medications, adverse events (AEs), serious adverse events (SAEs), disease response, and survival status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 2, single-arm, open-label study evaluating the efficacy and safety of subcutaneous Mosunetuzumab in patients with low-tumor-burden follicular lymphoma. All participants will receive the same intervention product without randomization.
| Arm | Type | Receives |
|---|---|---|
| Patients with follicular lymphoma with low tumor burden who have not been previously treated | Experimental | Drug: Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- at least 18 years old
- Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)
- Low tumor burden by GELF criteria
- No prior therapy except surgery or radiotherapy for disease that was previously localized
- Ann Arbor Stage III or IV disease
Key exclusion criteria (9 listed)
- 1. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count > 200 cell/mcl
- 2. Any of the following laboratory abnormalities:
- Presence or history of CNS involvement by lymphoma
- 4. Prior history of malignancies other than Lymphoma (except for Basal Cell or Squamous Cell Carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 2 years
- Contraindication to use Mosunetuzumabor known sensitivity or allergy
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 is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles. | Drug | Patients with follicular lymphoma with low tumor burden who have not been previously treated |
Primary outcome
Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
Time frame: 6 months
ORR is defined as the proportion of patients who achieved Complete Response or Partial Response determined by Lugano 2014 criteria as assessed by investigators at 6 months after initiation of treatment and prior to the initiation of any subsequent anti-lymphoma therapy. Patients without post-baseline disease assessments will be considered non-responders.
8 secondary outcomes
Progression Free Survival -PFS
Time frame: up to 24 months after last treatment dose
Duration of response -DOR
Time frame: up to 24 months after last treatment dose
Complete Response Rate - CRR - Lymphoma (FACT-Lym) subscale.
Time frame: up to 24 months after last treatment dose
Duration of Complete Response -DOCR
Time frame: up to 24 months after last treatment dose
Time to Next Treatment -TTNT
Time frame: up to 24 months after last treatment dose
Overall Survival -OS
Time frame: up to 24 months after last treatment dose
Statistical Analysis for Safety
Time frame: from first dose through 90 days after administration of last dose
Health related quality of life
Time frame: whole treatment period- 6 months
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 11 Aug 2026.
- 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.
Irit Avivi, Prof principal investigator
Tel-Aviv Sourasky Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells. in people with Follicular Lymphoma, run by Tel-Aviv Sourasky Medical Center at 4 sites in Israel.
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 9 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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 Irit Avivi, Prof (+972 3-6974452, iritavi@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria (time frame: 6 months). 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 11 Aug 2026.