Clinical trial · Interventional
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).
NCT07191249CI-TRIAL-00121413SUNFLOWrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with follicular lymphoma with low tumor burden who have not been previously treated
- description
- 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.
- interventionNames
- 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.
Primary outcomes (1)
- measure
- Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. Hemoglobin, without transfusion, 9 g/dL 2. ANC 1.0 109/L 3. 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 Exclusion Criteria: * 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: 1. Total Bilirubin or GGT or AST or ALT \> 3 X ULN. 2. 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.