Study on the Safety of Using Modified T Cells to Treat Relapsed or Resistant B Cell Non-Hodgkin Lymphomas

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT03277729

Provider View

This clinical trial is testing a new treatment using a patient's own T cells, which are modified to target and attack B cell non-Hodgkin lymphoma that has returned or not responded to previous treatments. The study aims to find the best dose, ensure the treatment is safe, and evaluate its effectiveness.

Patient Parameters

Program Overview

The purpose of this study is to determine the safest and most effective dose of genetically modified T cells for treating B cell non-Hodgkin lymphoma that has either come back after treatment or did not respond to previous treatments. The study will also assess the safety and effectiveness of this treatment approach.

Description

In this study, patients will undergo a process called leukapheresis to collect their T cells. These cells are then modified in the lab to specifically target cancer cells. Patients may receive additional treatment if needed to control their disease before the main treatment. They will receive chemotherapy drugs, cyclophosphamide, and possibly fludarabine, through an IV. After 36-96 hours, the modified T cells will be infused back into the patient over 20-30 minutes.

Participants will be involved in the study for about 15 months, which includes the time needed to prepare the T cells, the infusion, and follow-up for about 12 months after the infusion. After completing the study treatment, patients will be monitored for at least 15 years to ensure long-term safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma, including specific subtypes like mantle cell, follicular, or diffuse large B cell lymphoma.
  • The cancer must have returned after treatment or not responded to previous treatments.
  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
  • Must have evidence of CD20 expression on cancer cells.
  • Must have adequate kidney, liver, lung, and heart function as determined by specific medical tests.
  • Must have measurable disease that can be tracked using imaging techniques.
  • Must not have uncontrolled infections or autoimmune diseases requiring treatment.
  • Must not be on any other investigational treatments between enrollment and chemotherapy.

Exclusion Criteria

  • Active autoimmune disease requiring treatment.
  • Need for high-dose corticosteroid therapy.
  • HIV positive.
  • Pregnant or breastfeeding women.
  • Recent significant heart problems.
  • Severe allergic reactions to study drugs.
  • Uncontrolled seizures or other serious brain conditions.
  • Recent participation in another clinical trial.
  • Recent treatment with certain cancer therapies.
  • Previous treatment with CD19-targeted CAR T cells without recovery of normal B cells.
  • Active graft versus host disease.
  • Uncontrolled active infections.
  • Other progressing cancers requiring treatment, except for certain skin or prostate cancers.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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