Actively Recruiting
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2026-01-05
40
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for 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). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. 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). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.
CONDITIONS
Official Title
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the participant or legally authorized representative
- Willing to provide tissue from a fresh biopsy or diagnostic tumor biopsy before starting treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Confirmed mantle cell lymphoma diagnosis with relapse or refractory disease after at least one prior systemic therapy
- Relapse confirmed by hematopathology review unless approved otherwise
- Tumor positive for CD20 after most recent therapy
- Active disease requiring treatment
- Measurable disease by Lugano criteria or confirmed bone marrow involvement
- Fully recovered from acute toxic effects of prior anti-cancer therapy except alopecia
- Adequate blood counts: ANC ≥ 1,000/mm3 without bone marrow involvement; platelets ≥ 75,000/mm3 without bone marrow involvement
- Hemoglobin ≥ 8 g/dL unless anemia is due to disease involvement
- Liver enzymes and bilirubin within specified limits
- Normal kidney function or creatinine clearance ≥ 50 mL/min
- Blood clotting times within specified limits
- Left ventricular ejection fraction ≥ 40%
- Oxygen saturation ≥ 92% on room air
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control during and after treatment according to specified timelines
You will not qualify if you...
- Prior treatment with a T-cell engaging bispecific antibody
- Recent treatment with therapeutic anti-cancer antibodies, chemotherapy, radiation, or radio-/toxin-immunoconjugates within specified time frames
- Prior BTK inhibitor treatment exceeding 180 cumulative days
- Prior CAR T cell therapy within 6 months
- Prior allogeneic stem cell transplant
- Autologous stem cell transplant within 3 months
- Major surgery within 30 days before treatment start
- Systemic steroid therapy exceeding 20 mg/day prednisone or equivalent with limited exceptions
- Recent use of systemic immunosuppressive medications
- Recent live virus vaccinations or planned during treatment
- Requirement for strong CYP3A4 inhibitors or inducers
- History of solid organ transplantation
- Known hypersensitivity to study drugs or related antibodies
- Concurrent participation in another therapeutic clinical trial
- History of other malignancies unless disease-free for at least 2 years or specific exceptions
- History of myeloid malignancies or related genetic abnormalities
- Malabsorption or gastrointestinal conditions affecting drug absorption
- Active central nervous system lymphoma or other CNS diseases with some exceptions
- History of progressive multifocal leukoencephalopathy or hemophagocytic lymphohistiocytosis
- Recent gastrointestinal ulcers
- Known bleeding disorders
- Significant cardiovascular disease with some exceptions
- Inability to swallow or retain oral medication
- Active infection or recent major infections
- Significant liver disease
- Suspected or latent tuberculosis
- Active hepatitis B or C infections with specific conditions for eligibility
- Active HIV infection unless controlled on therapy
- Pregnant or breastfeeding women or those unwilling to comply with birth control
- Any condition judged by the investigator to prevent safe participation or compliance with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
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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