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OncoMatch/Clinical Trials/NCT05849857

Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries

Is NCT05849857 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Mosunetuzumab for lymphoma, follicular.

Phase 2RecruitingOslo University HospitalNCT05849857Data as of May 2026

Treatment: MosunetuzumabIn this clinical trial adult patients diagnosed with follicular lymphoma and relapse or progression of disease within 24 months of starting first line treatment will be treated with mosunetuzumab. This is a bispecific antibody, a new type of immunotherapy that redirects the bodies own immune cells (T-cells) to attack and kill the lymphoma cells. The main question the trial aims to answer is if mosunetuzumab works better than standard treatments in this sub-group of patients. Patients will receive mosunetuzumab as injections in the abdominal subcutaneous fat once a week for the three first doses, then every third week 7 times. If all signs of disease are gone as evaluated by PET-CT images, the treatment is stopped. If signs of disease remain on PET-CT images, the patients can receive treatment every third week for up to a total of one year. After the end of treatment, patients are followed two years in the trial for signs of progression or relapse.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 negative

CD20-negative lymphoma [excluded]

Performance status

WHO 0–2

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: anti-CD20 antibody (rituximab, obinutuzumab) — first line

relapse or progression within 24 months of starting first line treatment containing a monospecific anti-CD20 antibody (such as rituximab or obinutuzumab...)

Cannot have received: systemic therapy

Received 2 or more previous treatment lines

Cannot have received: allogeneic hematopoietic stem cell transplant

Prior allogeneic hematopoietic stem cell transplant

Lab requirements

Blood counts

Impaired bone marrow function (neutrophils < 1.0 x 10^9/L or platelets < 50 x 10^9/L) unless due to lymphoma involvement

Kidney function

Impaired renal function not caused by lymphoma, defined as calculated creatinine clearance ≤ 40 ml/minute

Liver function

Impaired liver function not caused by lymphoma, defined as serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome) or serum ALT and AST > 3 x ULN

Cardiac function

Severe cardiac disease: impaired cardiac function (NYHA class III or IV), myocardial infarction within the last 6 months, unstable arrythmias and/or unstable angina pectoris

Impaired bone marrow function (neutrophils < 1.0 x 10^9/L or platelets < 50 x 10^9/L) unless due to lymphoma involvement. Impaired liver function not caused by lymphoma, defined as serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome) or serum ALT and AST > 3 x ULN. Impaired renal function not caused by lymphoma, defined as calculated creatinine clearance ≤ 40 ml/minute. Severe cardiac disease: impaired cardiac function (NYHA class III or IV), myocardial infarction within the last 6 months, unstable arrythmias and/or unstable angina pectoris.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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