Transpocart19

TranspoCART19 is an innovative cell therapy being studied in a Phase I/IIa clinical trial for patients with relapsed or refractory B-cell lymphoma. This trial aims to evaluate the safety, determine the optimal dose, and assess the effectiveness of TranspoCART19 cells in treating this challenging form of cancer. The study involves genetically modifying patients’ own T lymphocytes to target CD19, a protein found on B-cell lymphomas, potentially offering a new treatment option for those who have not responded to previous therapies.

Table of Contents

What is TRANSPOCART19?

TRANSPOCART19 is an innovative medical treatment being studied for patients with relapsed or refractory B-cell lymphoma. This means it’s designed for people whose lymphoma has either come back after initial treatment or hasn’t responded well to previous treatments.[1]

TRANSPOCART19 is classified as a cell therapy, which is a type of treatment where a patient’s own cells are modified to fight their disease. Specifically, it’s considered an advanced therapy that uses genetically modified T lymphocytes (a type of white blood cell) to target cancer cells.[1]

How Does TRANSPOCART19 Work?

TRANSPOCART19 works by using a patient’s own T cells, which are an important part of the immune system. Here’s a simplified explanation of the process:

  1. T cells are collected from the patient’s blood through a process called lymphapheresis.
  2. These cells are then genetically modified in a laboratory using a system called Sleeping Beauty transposon.
  3. The modification gives the T cells the ability to recognize and attack cancer cells that have a specific marker called CD19 on their surface.
  4. The modified cells, now called TRANSPOCART19, are then given back to the patient through an intravenous infusion (a drip into a vein).

Once in the body, these modified T cells can potentially seek out and destroy cancer cells that have the CD19 marker, which is commonly found on B-cell lymphomas.[1]

Who Can Receive TRANSPOCART19?

TRANSPOCART19 is being studied for patients with several types of B-cell lymphomas that have not responded well to other treatments. These include:

  • Diffuse large B-cell lymphoma that has relapsed or not responded after at least two other treatments
  • Primary diffuse large B-cell CNS lymphoma that has not responded to or has come back after treatment
  • Mantle cell lymphoma that has not responded to at least one previous treatment
  • Follicular lymphoma (grades 1, 2, or 3a) that has not responded to at least two previous treatments
  • Marginal zone lymphoma that has not responded to at least two previous treatments

Patients must be between 18 and 80 years old and meet certain health criteria to be eligible for the study.[1]

Clinical Trial Objectives

The ongoing clinical trial for TRANSPOCART19 has several important goals:

  • To determine if TRANSPOCART19 is safe to use in patients
  • To find the right dose of TRANSPOCART19 that can be effective without causing too many side effects
  • To see how well TRANSPOCART19 works in treating B-cell lymphomas
  • To understand how long the treatment effects last
  • To study how long the modified T cells stay in the patient’s body
  • To assess the impact of the treatment on patients’ quality of life

The trial is divided into two phases. Phase I focuses on safety and finding the right dose, while Phase II looks at how effective the treatment is.[1]

Potential Benefits

If successful, TRANSPOCART19 could offer several potential benefits for patients with hard-to-treat B-cell lymphomas:

  • A new treatment option for patients who have not responded to other therapies
  • Possibility of achieving remission (when cancer signs and symptoms decrease or disappear)
  • Potential for longer survival without the cancer progressing
  • A personalized approach using the patient’s own immune cells

However, it’s important to remember that these potential benefits are still being studied and are not guaranteed.[1]

Possible Side Effects

As with any new treatment, TRANSPOCART19 may cause side effects. The clinical trial is carefully monitoring for:

  • Cytokine release syndrome (CRS): A condition where the immune system becomes overactive, potentially causing fever, low blood pressure, and other symptoms
  • Neurological toxicity: Side effects that affect the nervous system
  • Other adverse events, particularly those that are severe (grade III or IV)

The study will closely track any side effects in the first month after treatment and continue monitoring for up to two years.[1]

Quality of Life Considerations

An important aspect of the TRANSPOCART19 study is assessing how the treatment affects patients’ overall quality of life. Participants will be asked to complete questionnaires before treatment, and then at 3 months, 6 months, and one year after receiving TRANSPOCART19. This information will help researchers understand not just how effective the treatment is at fighting cancer, but also how it impacts patients’ daily lives and well-being.[1]

Aspect Details
Trial Name Phase I/IIa study of TranspoCART19 infusion for relapsed or refractory B-cell lymphoma
Treatment TranspoCART19 (genetically modified autologous T lymphocytes)
Target Condition Relapsed or refractory B-cell lymphoma
Main Objectives Evaluate safety, determine optimal dose, assess efficacy
Key Eligibility Age 18-80, specific B-cell lymphoma types, failed previous treatments
Administration Intravenous infusion of cell suspension
Primary Endpoints Safety assessment, maximum tolerated dose, response rate at 3 months
Secondary Endpoints Duration of response, survival rates, quality of life, biomarker identification

Ongoing Clinical Trials on Transpocart19

  • Study of TranspoCART19 cell therapy for patients with CD19-positive acute lymphoblastic leukemia that is resistant or refractory to treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain
  • Study of TranspoCART19 Infusion for Patients with Relapsed or Refractory B-cell Lymphoma Using Genetically Modified T Lymphocytes

    Recruiting

    1 1 1 1
    Spain
  • Safety and Preliminary Efficacy of TranspoCART19 Cell Therapy in Patients with Refractory Lupus Nephritis (Phase I‑IIa)

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • B-cell lymphoma: A type of cancer that affects B lymphocytes, a kind of white blood cell that plays a crucial role in the immune system. B-cell lymphomas can be aggressive or slow-growing and may occur in various parts of the body.
  • Chimeric Antigen Receptor (CAR): A specially engineered receptor that can be added to immune cells, particularly T cells, to help them recognize and attack specific cancer cells more effectively.
  • Cytokine Release Syndrome (CRS): A systemic inflammatory response that can occur as a side effect of some immunotherapies, including CAR-T cell therapy. Symptoms can range from mild flu-like symptoms to more severe reactions requiring intensive care.
  • Lymphapheresis: A medical procedure used to collect lymphocytes (a type of white blood cell) from a patient's blood. In this trial, it's used to obtain T cells for genetic modification.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug or treatment that does not cause unacceptable side effects. Determining the MTD is often a key goal in early-phase clinical trials.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening. It's an important measure of a treatment's effectiveness.
  • Relapsed or Refractory: In cancer, 'relapsed' means the disease has returned after a period of improvement, while 'refractory' means the cancer has not responded to treatment or has stopped responding.
  • T lymphocytes: Also known as T cells, these are a type of white blood cell that plays a central role in the immune response. In this trial, they are genetically modified to target cancer cells.
  • TranspoCART19: The name of the investigational cell therapy being studied in this trial. It consists of genetically modified T cells designed to target CD19, a protein found on B-cell lymphomas.

References

  1. http://clinicaltrials.eu/trial/study-of-transpocart19-infusion-for-patients-with-relapsed-or-refractory-b-cell-lymphoma-using-genetically-modified-t-lymphocytes/