Actively Recruiting
A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
20
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of two drugs, glofitamab and obinutuzumab, in treating patients with mantle cell lymphoma that has returned or not responded to previous treatments after receiving CD19-directed CAR T-cell therapy. This phase II trial aims to determine how well these drugs work in this group of patients and to understand their effects on disease response and survival over time. The study also explores various biological markers to better understand treatment response and side effects. Participants receive obinutuzumab through an intravenous (IV) infusion on day 1 or days 1 and 2 of the first treatment cycle. Glofitamab is given by IV over 8 hours on days 8 and 15 of the first cycle, then over 2 to 8 hours on day 1 of cycles 2 through 12. Each cycle lasts 21 days, and treatment continues for up to 12 cycles unless the disease worsens or side effects become unacceptable. Blood samples and PET/CT scans are taken throughout the study to monitor the disease and treatment effects. After finishing the treatment cycles, patients are followed every 3 months for up to 2 years. During the study, researchers assess the proportion of patients whose cancer responds to treatment, including those who achieve complete responses. They also monitor progression-free survival, overall survival, and incidences of serious side effects such as cytokine release syndrome and neurologic toxicity. The study tracks how the body clears glofitamab and investigates relationships between various biological markers and treatment outcomes.
CONDITIONS
Brief Title
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mantle cell lymphoma that has relapsed or is refractory after prior treatment
- Previous treatment with anti-CD19 CAR T-cell therapy and intolerance or failure of Bruton's tyrosine kinase inhibition
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1 cm) by CT scan
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate blood counts: neutrophils ≥ 1,000/mcL and platelets ≥ 50,000/mcL
- Liver function: bilirubin ≤ 1.5 times upper limit normal or ≤ 3 times if Gilbert syndrome; AST/ALT ≤ 3 times upper limit normal
- Kidney function: creatinine ≤ 1.5 times upper limit normal or GFR ≥ 60 mL/min/1.73 m²
- HIV-positive patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or C infection with undetectable viral load
- Patients with treated brain metastases without progression and asymptomatic CNS involvement
- Patients with new or progressive brain metastases if asymptomatic and no immediate CNS treatment required
- Patients with prior or concurrent malignancies not interfering with study
- Agreement to use adequate contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Unresolved side effects from prior cancer treatment above grade 1 (except alopecia)
- Receiving other investigational agents
- Allergies to similar compounds as glofitamab or obinutuzumab
- Pregnant or breastfeeding women
- Active cytokine release syndrome or neurotoxicity requiring intervention within 14 days before enrollment
- Active infection requiring treatment or hospitalization within 14 days before enrollment
- Use of systemic immunosuppressive medications within 14 days before enrollment (except inhaled corticosteroids)
- Known or suspected chronic active Epstein Barr virus or cytomegalovirus infection
- History of hemophagocytic lymphohistiocytosis
- Prior treatment with glofitamab or similar bispecific antibodies targeting CD20 and CD3
- History of progressive multifocal leukoencephalopathy
- Current or past CNS diseases like stroke, epilepsy, CNS vasculitis, or neurodegenerative disease (except certain stable stroke cases)
- Significant cardiovascular disease such as severe heart failure or recent myocardial infarction
- Major surgery within 4 weeks before first treatment
- Recent live attenuated vaccine within 4 weeks before first treatment
- Positive SARS-CoV-2 test within 7 days prior to enrollment
- History of Waldenström macroglobulinemia
- Active autoimmune disease that could worsen with immunotherapy, except well-controlled or remote history cases
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 36 weeks (12 cycles of 21 days each)
Participants receive obinutuzumab intravenously on day 1 or days 1 and 2 of cycle 1, followed by glofitamab intravenously on days 8 and 15 of cycle 1 and on day 1 of cycles 2 through 12. Treatment cycles repeat every 21 days for up to 12 cycles, unless disease progression or unacceptable toxicity occurs. Blood samples and PET/CT scans are collected throughout treatment.
Approximately 12 treatment visits plus additional visits for blood sample collection and PET/CT scans
Duration - Up to 2 years
After completing study treatment, participants are followed every 3 months for up to 2 years to monitor response, survival, and safety.
Quarterly visits every 3 months for up to 2 years
Trial Site Locations
Total: 7 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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