OncoMatch/Clinical Trials/NCT06054776
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Is NCT06054776 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Glofitamab and Obinutuzumab for mantle cell lymphoma.
Treatment: Acalabrutinib · Glofitamab · Obinutuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 overexpression (positive by immunohistochemistry or flow cytometry after the most recent therapy)
Tumor must be positive for CD20 by immunohistochemistry or flow cytometry after the most recent therapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Relapsed or refractory disease after at least 1 prior line of systemic therapy
Cannot have received: T-cell engaging bispecific antibody
Prior treatment with a T-cell engaging bispecific antibody
Cannot have received: therapeutic anti-cancer antibody (rituximab)
therapeutic anti-cancer antibodies within 4 weeks (i.e. rituximab)
Cannot have received: radio- or toxin-immunoconjugate
radio- or toxin-immunoconjugates within 4 weeks
Cannot have received: chemotherapy
all other chemotherapy or radiation therapy within 2 weeks prior to day 1 of protocol therapy
Cannot have received: radiation therapy
all other chemotherapy or radiation therapy within 2 weeks prior to day 1 of protocol therapy
Cannot have received: BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, pirobrutinib)
Exception: Patients with <= 180 cumulative days on BTK inhibitor prior to enrollment are allowed, as long as they did not progress on treatment.
Prior exposure to a BTK inhibitor (including but not limited to ibrutinib, acalabrutinib, zanubrutinib, and pirobrutinib) for more than 180 cumulative days prior to enrollment. Patients with <= 180 cumulative days on BTK inhibitor prior to enrollment are allowed, as long as they did not progress on treatment.
Cannot have received: CAR-T cell therapy
Exception: within 6 months of day 1 of protocol therapy
Prior chimeric antigen receptor (CAR) T cell therapy within 6 months of day 1 of protocol therapy
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 3 months of day 1 of protocol therapy
Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy
Lab requirements
Blood counts
Without bone marrow involvement: ANC >= 1,000/mm^3, Platelets >= 75,000/mm^3; With bone marrow involvement: no minimal ANC, Platelets >= 30,000/mm^3; Hemoglobin >= 8 g/dL unless anemia is secondary to disease involvement
Kidney function
Normal creatinine per local laboratory reference range or creatinine clearance of >= 50 mL/min per 24 hour urine test or Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN (<= 3x ULN if hepatic involvement by lymphoma or Gilbert's disease); AST/ALT <= 2.5 x ULN (<= 5x ULN if hepatic involvement by lymphoma)
Cardiac function
Left ventricular ejection fraction (LVEF) >= 40%
Total bilirubin <= 1.5 x ULN (<= 3x ULN if hepatic involvement by lymphoma or Gilbert's disease); AST/ALT <= 2.5 x ULN (<= 5x ULN if hepatic involvement by lymphoma); Normal creatinine per local laboratory reference range or creatinine clearance of >= 50 mL/min per 24 hour urine test or Cockcroft-Gault formula; Without bone marrow involvement: ANC >= 1,000/mm^3, Platelets >= 75,000/mm^3; With bone marrow involvement: no minimal ANC, Platelets >= 30,000/mm^3; Hemoglobin >= 8 g/dL unless anemia is secondary to disease involvement; Left ventricular ejection fraction (LVEF) >= 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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