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A Study Evaluating the Safety, Pharmacokinetics (what the body does to a drug), and Efficacy of Mosunetuzumab given subcutaneously (SC) or intravenously (IV) plus Lenalidomide (+Len) in Patients with Follicular Lymphoma
EU CTIS ID: 2023-507236-20-00
What this study is testing
Non-Randomized Stage R/R FL Cohort: To evaluate the maximum tolerated dose (MTD) and select the recommended Phase II dose (RP2D) of mosunetuzumab (Mosun) + lenalidomide (Len) Non-Randomized Stage 1L FL Cohort: To evaluate the treatment efficacy of Mosun+Len by measuring response rate Randomized Stage: To assess the pharmacokinetics non inferiority of the Mosun SC+Len regimen compared to the reference Mosun IV+Len regimen, each in combination with Len
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- R/R FL after treatment with at least one prior systemic lymphoma therapy which includes prior immunotherapy or chemoimmunotherapy
- Previously untreated patients with FL must require systemic therapy assessed by investigator based on GELF criteria and have a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5
- Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 as determined by the local laboratory
- Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)
- At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
You likely can't join if
- Any history of Grade 3b FL
- Any History of disease transformation and/or diffuse large B-cell lymphoma
- Active or history of central nervous system lymphoma or leptomeningeal infiltration
- Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy
- Prior standard or investigational anti-cancer therapy as specified
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.