Actively Recruiting
Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Led by University of California, San Francisco · Updated on 2026-04-20
30
Participants Needed
3
Research Sites
215 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib 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). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
CONDITIONS
Official Title
Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Life expectancy of at least 12 weeks
- ECOG performance status less than 2 (Karnofsky greater than 60%)
- Previously treated mantle cell lymphoma relapsed or refractory after at least one prior systemic therapy including anti-CD20 antibody and alkylator chemotherapy
- At least one measurable nodal lesion larger than 1.5 cm or extranodal lesion larger than 1.0 cm that is FDG-avid
- Availability of leftover tissue from progression for pathology confirmation
- Hemoglobin 9 g/dL or higher within 7 days prior to screening
- Absolute neutrophil count at least 1.0 x 10^9/L within 7 days prior to screening
- Platelets at least 75 x 10^9/L or at least 50 x 10^9/L if due to bone marrow involvement within 7 days prior to screening
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) or up to 3 times ULN for Gilbert syndrome or lymphoma
- AST and ALT less than or equal to 2.5 times institutional ULN
- Creatinine clearance at least 50 mL/min
- aPTT or PTT less than or equal to 1.5 times ULN
- PT or INR less than or equal to 1.5 times ULN
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and after treatment
- Men agree to use contraception or abstain during and after treatment
- Ability to provide informed consent and comply with study requirements
- Recovery to grade 1 or less of prior treatment-related adverse events except alopecia and grade 2 peripheral neuropathy
- Ability to swallow oral medications
- Negative hepatitis B PCR if positive anti-HBc antibody and use of antiviral prophylaxis
- History of treated and cured hepatitis C or undetectable viral load if on treatment
You will not qualify if you...
- Pregnant or planning pregnancy during the study or specified periods after treatment
- Breastfeeding until at least one week after stopping pirtobrutinib
- Prior major bleeding or grade 3 or higher arrhythmia on BTK inhibitor treatment
- Discontinuation of covalent BTK inhibitor due to disease progression (intolerance allowed)
- Previous use of CD20/CD3 bispecific antibodies for lymphoma
- Allogeneic stem cell transplant within 6 months or active immunosuppression or graft versus host disease
- Solid organ transplant
- Radiotherapy within 2 weeks before study treatment or within 4 weeks without measurable lesions outside radiation field
- Autologous stem cell transplant within 90 days
- CAR T-cell therapy within 60 days or ongoing grade 2 or higher toxicity
- Monoclonal antibodies or antibody-drug conjugates within 4 weeks
- Radioimmunoconjugates within 12 weeks
- Systemic immunosuppressive medications within 2 weeks or five half-lives except low-dose corticosteroids
- Live attenuated vaccines within 4 weeks before treatment or anticipated during study or within 5 months after treatment
- Active central nervous system lymphoma or leptomeningeal infiltration
- Current or history of CNS disease including stroke or epilepsy unless no recent events or deficits
- Active second malignancy unless in remission with life expectancy over 2 years
- Major surgery under general anesthesia within 30 days before treatment
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of autoimmune diseases except stable hypothyroidism, immune thrombocytopenic purpura, autoimmune hemolytic anemia, or well-controlled type I diabetes
- Significant cardiovascular disease including recent myocardial infarction, unstable arrhythmia, or low ejection fraction
- QTcF greater than 470 msec
- Significant pulmonary disease interfering with therapy
- History of progressive multifocal leukoencephalopathy
- Active infection including SARS-CoV-2 or recent severe infections
- Use of warfarin or vitamin K antagonists requiring therapeutic anticoagulation
- Known or suspected hemophagocytic lymphohistiocytosis
- Positive HIV test
- History of bleeding disorders
- Active malabsorption or conditions affecting gastrointestinal absorption
- Hypersensitivity to pirtobrutinib excipients or study medications
- Ongoing therapy with strong CYP3A inhibitors or inducers without adequate washout
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California, Davis
Davis, California, United States, 95616
Actively Recruiting
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
CONTACT
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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