NCT06054776

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting now Phase 2 Last updated 5 January 2026

What this trial tests

Phase 2 trial testing Acalabrutinib in Mantle Cell Lymphoma in 40 participants. Currently enrolling.

Timeline

2 December 2024

Primary endpoint
16 October 2026

16 October 2026

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	2 December 2024
Primary completion	16 October 2026
Estimated completion	16 October 2026
Sites	1 location across United States

Drugs / interventions tested

• Acalabrutinib (ACALABRUTINIB) — full drug profile →
• Biospecimen Collection — full drug profile →
• Bone Marrow Biopsy
• Computed Tomography
• Echocardiography
• Glofitamab (glofitamab) — full drug profile →
• Multigated Acquisition Scan
• Obinutuzumab — full drug profile →
• Positron Emission Tomography

Conditions studied

• Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

City of Hope Medical Center

Who can join

18 and older, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Development and Application of Bispecific Antibodies in B-Cell Non-Hodgkin Lymphoma.
   Sun L, Romancik JT. · · 2025 · cited 5× · PMID 39997328 · DOI 10.3390/jpm15020051
2. Empowering macrophages: the cancer fighters within the tumour microenvironment in mantle cell lymphoma.
   Nylund P, Nikkarinen A, Ek S, Glimelius I. · · 2024 · cited 5× · PMID 38566987 · DOI 10.3389/fimmu.2024.1373269
3. Leveraging the Immunomodulatory Potential of Ibrutinib for Improved Outcomes of T Cell-Mediated Therapies of B Cell Malignancies: A Narrative Review.
   Miklos DB, Riedell PA, Bokun A, Chavez JC, et al · · 2025 · cited 4× · PMID 40035913 · DOI 10.1007/s11523-025-01133-9
4. Bispecific Antibodies for Lymphoid Malignancy Treatment.
   Bisio M, Legato L, Fasano F, Benevolo Savelli C, et al · · 2024 · cited 4× · PMID 39796723 · DOI 10.3390/cancers17010094
5. Bispecific Antibodies and Antibody-Drug Conjugates in Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma, Focusing on Diffuse Large B-Cell Lymphoma.
   Caserta S, Campo C, Cancemi G, Neri S, et al · · 2025 · cited 3× · PMID 40805178 · DOI 10.3390/cancers17152479
6. T-cell-based therapies for treating relapsed or refractory mantle cell lymphoma.
   Epstein-Peterson ZD, Palomba ML. · · 2024 · cited 2× · PMID 39644075 · DOI 10.1182/hematology.2024000657
7. T-Cell-Redirecting Immunotherapies in Relapsed/Refractory Mantle Cell Lymphoma: Current Evidence, Sequencing, and Future Directions.
   Caserta S, Martino EA, Vigna E, Bruzzese A, et al · · 2026 · cited 1× · PMID 41207679 · DOI 10.1111/ejh.70063
8. Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions.
   Tavarozzi R, Maher N, Catania G, Zacchi G, et al · · 2026 · PMID 41986622 · DOI 10.1038/s41375-026-02942-1