Study on Brexucabtagene Autoleucel (KTE-X19) for Treating Relapsed or Hard-to-Treat B-Cell Cancers

Sponsor: Kite, A Gilead Company

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04162756

Provider View

This clinical trial is providing access to a new treatment, Brexucabtagene Autoleucel (KTE-X19), for patients with B-cell cancers that have returned or are not responding to treatment. The study includes two groups: one for patients before the treatment is widely available, and another for those whose treatment did not meet certain standards.

Patient Parameters

Program Overview

The main goal of this study is to offer Brexucabtagene Autoleucel (KTE-X19) to patients with relapsed or refractory B-cell cancers, specifically mantle cell lymphoma (MCL). The study has two groups: one for patients who need the treatment before it becomes widely available, and another for those whose treatment did not meet specific quality standards. Participants who receive the treatment can join a long-term follow-up study to monitor their progress.

Description

This study is open to patients with B-cell cancers that have returned or are not responding to treatment. It includes two groups:

  • Cohort 1: For patients who need access to KTE-X19 before it is commercially available.
  • Cohort 2: For patients whose commercially produced KTE-X19 did not meet certain quality standards.

Participants who receive KTE-X19 will have the option to join a separate long-term follow-up study to continue monitoring their health and treatment outcomes.

Eligibility Criteria

Inclusion Criteria

Cohort 1:

  • Diagnosed with mantle cell lymphoma (MCL) confirmed by specific tests.
  • Previously received at least one treatment for MCL, which must have included:
    • Chemotherapy with anthracycline or bendamustine, or
    • Anti-CD20 antibody therapy, or
    • Treatment with a Bruton's tyrosine kinase inhibitor (BTKi) like ibrutinib or acalabrutinib.
  • Cancer has returned or not responded to the last treatment.
  • MRI of the brain shows no cancer in the central nervous system.
  • Good overall health with a performance status of 0 or 1.
  • Sufficient blood cell counts and organ function.
  • Women of childbearing age must have a negative pregnancy test.
  • At least one measurable tumor.

Cohort 2:

  • Patients whose KTE-X19 treatment did not meet specific quality standards.

Exclusion Criteria

Cohort 1:

  • Uncontrolled infections or those needing IV treatment.
  • History of HIV or active hepatitis B or C.
  • History of cancer in the brain or central nervous system.
  • History of certain brain disorders or autoimmune diseases affecting the brain.

Cohort 2:

  • Any medical condition that might affect the safety or effectiveness of the treatment, as determined by the doctor.

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