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NCT06054776 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT06054776: Recruiting Phase 2 study of Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.

NCT06054776 is a Phase 2 study of Mantle Cell Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 40 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06054776, a Phase 2 study of Mantle Cell Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Defined as AEs that is at least possibly related to study treatment and not related to underlying lymphoma. Toxicities will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Cytokine release syndrome (CRS) severity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Criteria. Observed toxicities will be summarized by type, severity, and attribution.

Conditions Studied

Mantle Cell Lymphoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • DRUG Acalabrutinib
  • PROCEDURE Echocardiography

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-12-02
Est. Completion 2026-10-16
Phase Phase 2
City of Hope Medical Center

582 total trials

What NCT06054776 shows while recruiting

NCT06054776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower).

The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06054776 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06054776 about?

NCT06054776 is a clinical study titled "Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma". 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). Acalab...

What is the current status of trial NCT06054776?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-12-02. Estimated completion is 2026-10-16.

What conditions does trial NCT06054776 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma.

What interventions are being tested in trial NCT06054776?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Acalabrutinib (DRUG), Echocardiography (PROCEDURE).

Who is sponsoring clinical trial NCT06054776?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06054776 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Mantle Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06054776's enrollment target sits among peer trials

40 54th of 102 higher than 48 of 102 other Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06054776

Source: ClinicalTrials.gov NCT06054776, the US trial registry maintained by the National Library of Medicine. NCT06054776 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.