Study on CAR-T Therapy Followed by Bispecific Antibodies
Sponsor: Abramson Cancer Center at Penn Medicine
ClinicalTrials ID:NCT04889716
This clinical trial is testing the safety and effectiveness of two experimental drugs, mosunetuzumab and a combination of obinutuzumab and glofitamab, given after CAR-T cell therapy in patients with certain types of lymphoma.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of two experimental drugs, mosunetuzumab and a combination of obinutuzumab and glofitamab, when given after CAR-T cell therapy. This study is for patients who have already received a CAR-T cell infusion. Some participants will receive mosunetuzumab, while others may receive the combination of obinutuzumab and glofitamab later in the study.
Eligibility Criteria
Inclusion Criteria
- Have a life expectancy of at least 12 weeks.
- Have a history of relapsed or refractory large B-cell lymphoma, including transformed follicular lymphoma and follicular lymphoma Grade 3B, that has not responded to at least one previous standard treatment.
- Have no other available treatments expected to improve survival.
- Have had a PET/CT scan, CT scan, or MRI before CAR-T cell therapy showing at least one measurable tumor.
- Have a PET/CT scan, CT scan, or MRI after CAR-T cell therapy showing at least one measurable tumor.
- Be at least 30 days post-CAR-T cell infusion at the time of study enrollment.
- Have adequate lab test results.
- Be willing to use effective birth control methods.
Exclusion Criteria
- Have had severe cytokine release syndrome (CRS) or unresolved CRS after CAR-T therapy.
- Have had significant neurologic side effects or unresolved neurologic issues after CAR-T therapy.
- Cannot comply with study requirements, including hospital stays and activity restrictions.
- Are pregnant, breastfeeding, or planning to become pregnant during the study or shortly after.
- Have had a solid organ transplant.
- Have a history of autoimmune diseases like lupus or rheumatoid arthritis.
- Have had progressive multifocal leukoencephalopathy (PML).
- Have had severe allergic reactions to antibody treatments.
- Have other cancers that could interfere with the study.
- Have significant heart or lung diseases.
- Have active infections or recent major infections requiring hospitalization.
- Have had major surgery recently.
- Have received a live vaccine recently or plan to during the study.
- Have used certain immunosuppressive medications recently.
- Have a history of drug or alcohol abuse in the past year.
- Have any serious medical conditions that could affect participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Nebraska Medical Center | 68198 | Omaha | Nebraska |
| Abramson Cancer Center of the University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
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