NCT07191249RecruitingPhase 2
Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .
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).
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 5 Jan 2026
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Diseases
- Follicular lymphoma
- NCT number
- NCT07191249
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 5 Jan 2026 to the primary completion date, 1 Apr 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence or history of CNS involvement by lymphoma
- Contraindication to use Mosunetuzumabor known sensitivity or allergy
Lab values
- 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
Age
- 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
Other
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Hadassah University Hospital-Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center (TASMC) - Ichilov Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.