Actively Recruiting
Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-26
23
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of two experimental drug treatments, mosunetuzumab or the combination of obinutuzumab and glofitamab, given after CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma, including transformed follicular lymphoma. The study focuses on patients who have already received a CAR T-cell infusion and are seeking additional treatment options. It is a Phase II clinical trial sponsored by the Abramson Cancer Center at Penn Medicine. Participants are assigned to one of two groups: Cohort 1 receives mosunetuzumab starting with a fractionated dosing schedule in cycle 1 followed by 60 mg and then 30 mg every 21 days for up to 17 cycles. Cohort 2 receives obinutuzumab 1000 mg on cycle 1 day 1 and glofitamab starting with a lower dose fractionated over two weeks in cycle 1 followed by 30 mg every 21 days for up to 12 cycles. All treatments are administered after standard-of-care CD19-directed CAR T-cell therapy. During the study, participants will undergo imaging scans such as PET/CT, CT, or MRI to measure the lymphoma lesions before and after CAR T-cell therapy and during treatment cycles. Researchers will monitor responses using the Cheson 14 criteria to assess complete metabolic response at 24 weeks. Safety is evaluated by tracking dose-limiting toxicities within 63 days of glofitamab infusion. Additional follow-up includes measuring response duration for up to five years after the last bispecific antibody dose. Participants will be closely observed through laboratory tests and clinical assessments throughout their involvement.
CONDITIONS
Brief Title
CAR-T Followed by Bispecific Antibodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 12 weeks
- Diagnosis of relapsed or refractory large B-cell lymphoma, including transformed follicular lymphoma and follicular lymphoma Grade 3B
- Previous failure to respond or relapse after at least one standard systemic treatment regimen containing an anthracycline and an anti-CD20 therapy
- No available therapy expected to improve survival
- Measurable lesion by PET/CT, diagnostic CT, or MRI within 56 days before CAR T-cell therapy
- Measurable disease by imaging at least 28 days after CAR T-cell infusion and before study treatment
- At least 30 days post CAR T-cell infusion at enrollment
- Adequate laboratory tests
- Willingness and ability to use proper contraceptive precautions
You will not qualify if you...
- History of grade 3 or higher cytokine release syndrome (CRS) after CAR-T therapy or unresolved CRS
- Grade 2 or higher neurologic toxicity after CAR-T therapy or active neurologic toxicity
- Inability to comply with hospitalization and activity restrictions
- Pregnant, lactating, or intending pregnancy during study or within 3 months after last bispecific antibody dose or 18 months after obinutuzumab
- Prior solid organ transplantation
- Active systemic autoimmune disease or requiring chronic immunosuppressive therapy
- History of progressive multifocal leukoencephalopathy (PML)
- Severe allergic reactions to monoclonal antibody therapy
- History of other malignancy affecting study compliance or results
- Significant cardiovascular disease (e.g., NYHA Class III/IV, recent myocardial infarction)
- Active pulmonary disease requiring oxygen or corticosteroids
- Active infection requiring IV antibiotics or hospitalization within 2 weeks prior to study drug administration
- Recent major surgery within 4 weeks prior to study drug
- Administration of live attenuated vaccine within 4 weeks before study drug or planned during study
- Use of systemic immunosuppressive medications except low-dose corticosteroids within 2 weeks prior to study drug
- History of drug or alcohol abuse within 12 months
- Any serious medical condition or lab abnormality that precludes safe participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 51 weeks depending on bispecific antibody regimen
Participants receive sequential treatment starting with standard-of-care CD19-directed CAR T-cell therapy followed by bispecific antibody therapy with either mosunetuzumab or obinutuzumab and glofitamab depending on cohort assignment.
Multiple visits for infusions during treatment cycles, including weekly and every 21-day schedules depending on the bispecific antibody
Duration - Up to 5 years from last dose of bispecific antibody therapy
Participants are monitored to assess response duration and safety after completing bispecific antibody therapy.
Periodic visits for response and safety assessments
Trial Site Locations
Total: 2 locations
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
2
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
R
Rachel Lundberg, PA-C
K
Kaitlin Kennard, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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