Zanubrutinib and CAR T-cell Therapy for Treating Recurrent or Hard-to-Treat Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05202782

Provider View

This study is exploring the effects of combining zanubrutinib, a drug that may stop cancer cell growth, with CAR T-cell therapy, a treatment using modified immune cells, to treat aggressive B-cell lymphomas that have returned or are not responding to treatment.

Patient Parameters

Program Overview

This phase II clinical trial is investigating whether the combination of zanubrutinib and CAR T-cell therapy can effectively treat patients with aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has come back or is not responding to treatment. Zanubrutinib may help stop cancer cells from growing by blocking certain enzymes. CAR T-cell therapy uses a patient's own T cells, which are modified to recognize and attack cancer cells. The study aims to see if using these treatments together can kill more cancer cells.

Description

The main goal of this study is to see if adding zanubrutinib to CAR T-cell therapy can improve the complete response rates in patients after six months, compared to past results. The study will also look at how many patients with a partial response to initial CAR T-cell therapy achieve a complete response after adding zanubrutinib. Other goals include measuring overall response rates, progression-free survival, and overall survival rates. The study will also assess any side effects and the impact on patients' quality of life.

Participants will first take zanubrutinib by mouth twice a day for 7-14 days. Then, they will receive standard CAR T-cell therapy through an IV. After that, they will continue taking zanubrutinib for 28-day cycles, repeating for up to 12 months, as long as the cancer does not progress and side effects are manageable.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has returned or is not responding to standard treatment.
  • Must be eligible for standard CAR T-cell therapy, which includes specific types of lymphoma as per medical guidelines.
  • Must have measurable disease according to specific medical criteria.
  • Must be 18 years or older.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must have a life expectancy of more than 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Must meet specific blood count and organ function requirements.
  • Must agree to use effective contraception during the study and for 180 days after the last treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be participating in other experimental treatments.
  • Cannot be taking certain medications that affect how zanubrutinib works.
  • Cannot be on high doses of steroids or other immune-suppressing drugs shortly before starting the study.
  • Cannot have active disease in the central nervous system.
  • Cannot have uncontrolled health issues like infections, heart problems, or psychiatric conditions that would interfere with the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have HIV.
  • Must be able to swallow pills.
  • Cannot have digestive issues that affect drug absorption.

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