Study on Metabolically Fit CD19 CAR T-cell Therapy with CD34 Selection for Patients with Difficult or Returning CD19+ Lymphomas and Leukemias

Sponsor: Medical University of South Carolina

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05702853

Provider View

This clinical trial is testing a new type of CAR T-cell therapy that includes a CD34 selection process to treat patients with certain types of lymphomas and leukemias that have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

This study is exploring a new CAR T-cell therapy that is designed to be more effective and safer for patients with certain types of B-cell lymphomas and leukemias. The therapy involves a special process to purify the CAR T-cells, which may help reduce side effects and improve the treatment's ability to fight cancer. The trial will test this therapy in adults with relapsed or refractory CD19+ non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Description

CAR T-cell therapy is a promising treatment for certain types of lymphomas and leukemias, but it can have issues like relapse and side effects. This study is testing a new version of CAR T-cell therapy that includes a CD34 tag to help purify the cells, which may make the treatment safer. The therapy also aims to improve the fitness of the CAR T-cells by enhancing their ability to persist and fight cancer. Researchers believe that this new approach will lead to a more effective treatment for patients with CD19+ lymphomas and leukemias that have not responded to other treatments or have returned.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of certain types of CD19+ lymphomas or leukemias, such as aggressive or indolent non-Hodgkin lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma.
  • Must have tried at least two previous treatments for their cancer, or one treatment for certain types like Burkitt lymphoma or mantle cell lymphoma, without success.
  • Must be at least 18 years old.
  • Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but can still care for themselves.
  • Must have measurable disease on scans or a bone marrow biopsy showing cancer involvement.
  • Must have adequate organ function, including blood counts, liver, heart, lung, and kidney function.
  • Must not have active infections like hepatitis B or C, or HIV, unless they are well-controlled.
  • Women of childbearing potential must not be pregnant and must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have active central nervous system (CNS) lymphoma.
  • Cannot have uncontrolled infections or a history of stroke or brain bleeding within the last 6 months.
  • Cannot have had another type of cancer within the last year, except for certain skin or localized cancers.
  • Cannot have a history of autoimmune diseases requiring treatment in the last year.
  • Cannot have received a live vaccine within 28 days before starting the study.
  • Cannot have had a stem cell transplant or CAR T-cell therapy recently.
  • Cannot have severe allergies to any study medications.
  • Cannot have any other serious illnesses that would make participation unsafe.

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