Local Production of CAR T-Cell Therapy for Treating B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia

Sponsor: John Lister

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05281809

Provider View

This study is testing a new way to make and use CAR T-cell therapy locally to treat patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia. The goal is to see if this method is safe and effective.

Patient Parameters

Program Overview

The trial aims to show that it's possible to safely create and give CAR T-cell therapy to patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia. This involves collecting cells from the patient, modifying them in a lab to fight cancer, and then returning them to the patient. The study will monitor the first few patients closely to ensure safety before continuing with more participants.

Description

In this study, patients will first be checked to see if they qualify and will be asked to give their consent to participate. Then, their blood cells will be collected through a process called apheresis. These cells will be modified in a lab to become CAR T-cells, which are designed to target and destroy cancer cells. Before receiving the CAR T-cells, patients will undergo chemotherapy to prepare their body. The modified cells will be infused back into the patient on day 0.

The first three patients will stay in the hospital for two weeks to monitor for any side effects, such as cytokine release syndrome (CRS) or neurological issues (ICANS). If these side effects are minimal, the study may adjust the hospital stay for future patients. After the initial hospital stay, patients will be followed closely until day 30, with regular check-ups to monitor their health and the effectiveness of the treatment. Follow-up will continue monthly until day 100, then every three months until two years, and every six months up to five years, or until the patient passes away.

All patients must agree to have their anonymized data shared with a research center for further study. The care provided in this study follows standard procedures for patients receiving commercial CAR T-cell products, with the only experimental aspects being the local production of the CAR T-cells and a blood test to detect these cells.

Eligibility Criteria

Inclusion Criteria

  • Patients with B-cell lymphoma or B-Acute Lymphoblastic Leukemia (B-ALL) who have no other curative treatment options and a limited life expectancy.
  • Must have a specific type of cancer, such as Diffuse Large B Cell Lymphoma or B-ALL, and have tried at least two treatments for lymphoma or one for B-ALL without success.
  • Cancer cells must show a marker called CD19.
  • Patients must be unable to receive commercially available CAR T-cell therapy.
  • Must have measurable cancer.
  • Patients who have relapsed after a stem cell transplant are eligible if they meet certain conditions.
  • Must be between 18 and 80 years old.
  • Women of childbearing age must test negative for pregnancy and use birth control during and after the study.
  • Men must agree to use birth control during and after the study.
  • Must have adequate heart and lung function.
  • Must have a performance score of 70 or higher, indicating they can care for themselves.
  • Must be able to understand and consent to the study.
  • Must agree to anonymous data reporting.

Exclusion Criteria

  • Active infections with HIV, hepatitis B, or hepatitis C.
  • Active untreated cancer in the brain or spinal cord.
  • Active bacterial, fungal, or viral infections.
  • Another active cancer requiring treatment.
  • Recent heart attack or heart disease.
  • Recent use of investigational drugs or certain cancer therapies.
  • Recent radiation therapy close to the time of cell collection.
  • Use of certain medications that cannot be stopped before cell collection.
  • Significant blood, liver, or kidney issues.
  • Pregnant or breastfeeding women.
  • Individuals unable to comply with study requirements or provide informed consent.

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