Study on Acalabrutinib, Obinutuzumab, and Glofitamab for Treating Relapsed or Hard-to-Treat Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06054776

Provider View

This clinical trial is exploring a new combination of drugs—Acalabrutinib, Obinutuzumab, and Glofitamab—to see if they can safely and effectively treat mantle cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new treatment combination for mantle cell lymphoma that has either come back after treatment or not responded to previous therapies. The treatment includes Acalabrutinib, which blocks a protein that helps cancer cells grow, Obinutuzumab, which helps the immune system attack cancer cells, and Glofitamab, which helps immune cells target and kill cancer cells. Researchers hope that using these drugs together will be a safe and effective way to treat this type of lymphoma.

Description

The study aims to evaluate how safe and tolerable the combination of Acalabrutinib and Glofitamab is for patients with relapsed or refractory mantle cell lymphoma (MCL). It also seeks to determine how well this treatment can achieve complete responses, where no signs of cancer are detectable.

Secondary goals include measuring how long patients remain free of cancer, their overall survival, and their quality of life during treatment. Researchers will also look at how the treatment affects the immune system and the genetic makeup of the cancer.

Participants will take Acalabrutinib orally twice a day, receive Obinutuzumab through an IV on specific days of the first cycle, and Glofitamab through an IV on certain days of each cycle. Treatment cycles repeat every 21 days for up to 12 cycles, unless the cancer progresses or side effects become too severe. Patients who respond well may continue taking Acalabrutinib alone after the initial treatment phase.

Throughout the study, participants will undergo various tests, including heart scans, imaging tests like PET/CT, and blood tests. Bone marrow biopsies may also be performed. After completing the study treatment, patients will have follow-up visits to monitor their health and response to the treatment for up to four years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Willing to provide a tumor sample before starting the study.
  • Age 18 or older.
  • Good overall health with an ECOG score of 0 to 2.
  • Diagnosed with mantle cell lymphoma that has returned or not responded to at least one previous treatment.
  • Cancer must be CD20 positive.
  • Active disease that requires treatment.
  • Measurable disease by imaging tests.
  • Adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after treatment.
  • Men must agree to use condoms or abstain from intercourse during and after treatment.

Exclusion Criteria

  • Previous treatment with a T-cell engaging bispecific antibody.
  • Recent treatment with certain cancer therapies or surgeries.
  • Prior use of BTK inhibitors for more than 180 days.
  • Recent CAR T-cell therapy or stem cell transplant.
  • Current use of high-dose steroids or certain immunosuppressive medications.
  • Recent live virus vaccinations.
  • History of solid organ transplant or severe allergic reactions to study drugs.
  • Participation in another clinical trial.
  • History of other cancers, except for certain treated cancers.
  • Active infections or significant liver disease.
  • Pregnant or breastfeeding women.
  • Any condition that may interfere with study participation.

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