Anti-CD19 CAR T-Cell Therapy for Chronic Lymphocytic Leukemia (CLL)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06364423

Provider View

This clinical trial is testing a new treatment called anti-CD19 CAR T-cell therapy for people with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that hasn't responded to standard treatments.

Patient Parameters

Program Overview

Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are types of blood cancer affecting certain white blood cells. These cancers can be hard to treat when they become advanced. Researchers are testing a new treatment that uses a person's own immune cells, called T cells, which are modified to target a protein called CD19 found on these cancer cells. This treatment, known as anti-CD19 CAR T-cell therapy, aims to help the immune system attack and kill cancer cells. The study is for adults aged 18 and older with CLL or SLL that hasn't been controlled with standard drugs.

Description

This study is exploring a new treatment for people with advanced Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The treatment involves modifying a person's own T cells to target and attack cancer cells with a protein called CD19. These modified cells, known as CAR T cells, are then returned to the patient's body to help fight the cancer.

Participants will first undergo screening, including imaging scans and heart tests. If a tumor sample isn't available, a new one may be taken to check for CD19. Participants will receive a drug to reduce leukemia cells in their blood, followed by a procedure called apheresis to collect T cells. These T cells will be genetically modified in the lab to target CD19.

Before receiving the modified T cells, participants will take drugs for three days to prepare their body. The CAR T cells will then be infused back into their bloodstream. Participants will stay in the hospital for at least nine days after the infusion to monitor for any side effects.

The study will follow participants for five years to monitor their health and the treatment's effectiveness. The main goals are to determine the safety of this new treatment and how well it works in reducing cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
  • Must be 18 years or older.
  • Cancer must be measurable by scans or blood tests.
  • Must have normal kidney function and heart health.
  • Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • No active infections, including hepatitis B or C.
  • Must have certain blood counts above specified levels.
  • Must have normal liver function unless cancer is affecting the liver.
  • Must have stopped any previous cancer treatments at least 14 days before starting the study treatment.
  • Must not have had previous CAR T-cell therapy.
  • Cancer cells must show CD19 protein.
  • Must agree to use effective birth control during and after the study.

Exclusion Criteria

  • Cannot be participating in other clinical trials.
  • Cannot have had previous CAR T-cell therapy.
  • Cannot have received certain vaccines recently.
  • Cannot have urgent medical needs due to cancer.
  • Cannot have active hemolytic anemia.
  • Cannot have active HIV infection.
  • Cannot have other cancers that required treatment in the past three years, except for certain skin cancers or fully treated breast cancer.
  • Cannot be pregnant or breastfeeding.
  • Cannot have active infections or uncontrolled medical conditions.
  • Cannot have significant neurological disorders.
  • Cannot have had a stem cell transplant.
  • Cannot be on high-dose steroids or certain medications.
  • Cannot have active brain metastases or cerebrospinal fluid cancer.
  • Cannot have used certain immune therapies recently.
  • Cannot have active substance abuse issues.
  • Cannot have active tumor lysis syndrome or other specific medical conditions.

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