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New treatment option for Large B-cell Lymphoma
Official title CAR-T Followed by Bispecific Antibodies
ClinicalTrials.gov ID: NCT04889716
What this study is testing
What is mosunetuzumab?
mosunetuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as RO7030816, BTCT4465A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Life expectancy of at least 12 weeks
- History of relapsed or refractory large B-cell lymphoma (including transformed follicular lymphoma, and follicular lymphoma Grade 3B) who have...
- PET/CT scan (preferred), diagnostic CT scan, or MRI prior to CAR-T cell therapy, with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for...
- PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for...
- Be at least 30 days after CAR T-cell infusion at time of study enrollment.
You likely can't join if
- Had \> Grade 3 cytokine release syndrome (CRS) by ASTCT criteria after CAR-T therapy or who have unresolved CRS after CAR-T therapy
- Had ≥ grade 2 neurologic toxicity by ASTCT criteria after CAR-T therapy or who have active neurologic toxicity after CAR-T therapy
- Inability to comply with protocol-mandated hospitalization and activities restrictions in the investigators' decision
- Pregnant or lactating, or intending to become pregnant during the study or within 3 months after the last dose of bispecific antibody or 18 months of...
- Prior solid organ transplantation
- Active systemic autoimmune disease or other disease requiring chronic immunosuppressive therapy
See the full eligibility criteria
- Life expectancy of at least 12 weeks
- History of relapsed or refractory large B-cell lymphoma (including transformed follicular lymphoma, and follicular lymphoma Grade 3B) who have relapsed after or failed to respond to at least one prior standard systemic...
- PET/CT scan (preferred), diagnostic CT scan, or MRI prior to CAR-T cell therapy, with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by...
- PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized...
- Be at least 30 days after CAR T-cell infusion at time of study enrollment.
- Adequate laboratory studies,
- Ability and willingness to take proper contraceptive precautions
- Had \> Grade 3 cytokine release syndrome (CRS) by ASTCT criteria after CAR-T therapy or who have unresolved CRS after CAR-T therapy
- Had ≥ grade 2 neurologic toxicity by ASTCT criteria after CAR-T therapy or who have active neurologic toxicity after CAR-T therapy
- Inability to comply with protocol-mandated hospitalization and activities restrictions in the investigators' decision
- Pregnant or lactating, or intending to become pregnant during the study or within 3 months after the last dose of bispecific antibody or 18 months of obinutuzumab, whichever comes later
- Prior solid organ transplantation
- Active systemic autoimmune disease or other disease requiring chronic immunosuppressive therapy
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
- Significant active pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease) requiring oxygen or corticosteroid use.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV...
- Recent major surgery within 4 weeks prior to first mosunetuzumab or glofitamab administration
- Active or chronic infection(s) would have increased risks for toxicity if treated with bispecific antibody therapy, thus will be excluded.
- Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
- Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid...
- History of drug or alcohol abuse within 12 months prior to screening in the investigator's judgment
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or...
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
- Philadelphia, Pennsylvania, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States; Philadelphia, Pennsylvania, United States. 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 ClinicalTrials.gov; the study team decides eligibility.