Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
20
Participants Needed
6
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.
CONDITIONS
Official 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 is relapsed or refractory after last treatment
- Previous treatment with anti-CD19 CAR T-cell therapy and failure or intolerance to Bruton's tyrosine kinase (BTK) inhibitors
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1 cm) on CT scan
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky ≥60%)
- Absolute neutrophil count ≥1,000/mcL
- Platelet count ≥50,000/mcL
- Total bilirubin ≤1.5 times the upper limit of normal (ULN) or ≤3 times ULN if Gilbert syndrome present
- AST/ALT ≤3 times ULN
- Creatinine ≤1.5 times ULN or glomerular filtration rate ≥60 mL/min/1.73 m²
- HIV patients eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months
- Hepatitis B patients eligible if surface antigen negative and viral load undetectable with proper management
- Hepatitis C patients eligible if viral load undetectable
- Patients with treated brain metastases without progression and asymptomatic
- Patients with new or progressive brain metastases asymptomatic and not requiring immediate CNS treatment
- Patients with prior or concurrent malignancies not interfering with study outcomes
- Women of childbearing potential and men must agree to use effective contraception during and after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Unresolved side effects greater than grade 1 from prior cancer therapy (except hair loss)
- Receiving other investigational agents
- Allergic reactions 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 (some exceptions apply)
- Known or suspected chronic active Epstein Barr virus or cytomegalovirus infection
- History of hemophagocytic lymphohistiocytosis
- Prior treatment with glofitamab or other bispecific antibodies targeting CD20 and CD3
- History of progressive multifocal leukoencephalopathy
- Current or past central nervous system diseases like stroke (with exceptions), epilepsy, CNS vasculitis, or neurodegenerative diseases
- Significant cardiovascular disease including advanced heart failure, recent myocardial infarction, unstable arrhythmias, or unstable angina
- Major surgery within 4 weeks before first treatment
- Live attenuated vaccine within 4 weeks before first treatment or anticipated during study
- Positive SARS-CoV-2 test within 7 days prior to enrollment
- Current or past Waldenström macroglobulinemia
- Active autoimmune disease that could worsen with immunotherapy, except well-controlled or remote history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 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
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
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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