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Study of TranspoCART19 Infusion for Patients with Relapsed or Refractory B-cell Lymphoma Using Genetically Modified T Lymphocytes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called relapsed or refractory B-cell lymphoma. This is a condition where the cancer has returned or does not respond to treatment. The study will use a treatment called TranspoCART19, which involves modifying a patient's own immune cells to help them better fight the cancer. These modified cells are called TranspoCART19 cells and are designed to target and destroy cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of TranspoCART19 in patients with this type of lymphoma. The study will be conducted in two phases. In the first phase, the focus will be on determining the safest dose of the treatment and monitoring any side effects. In the second phase, the effectiveness of the treatment will be assessed by observing how well it works in reducing or eliminating the cancer.

Participants in the study will receive the TranspoCART19 treatment through an infusion, which is a method of delivering the treatment directly into the bloodstream. The study will monitor participants over time to assess the treatment's impact on their cancer and overall health. The study aims to provide valuable information on the potential benefits and risks of using TranspoCART19 for treating relapsed or refractory B-cell lymphoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Blood tests and other necessary examinations are performed to ensure all criteria are met for participation in the trial.

  2. Step 2

    Lymphocyte collection

    A procedure called lymphapheresis is performed to collect T lymphocytes from the blood. This is necessary for the preparation of the study treatment.

    The procedure involves drawing blood, separating the T lymphocytes, and returning the remaining blood components to the body.

  3. Step 3

    Pre-treatment

    Before receiving the study treatment, a pre-treatment phase is conducted. This involves the administration of specific medications to prepare the body.

    Medications include fludarabine phosphate and cyclophosphamide monohydrate, given through an intravenous infusion. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Transpocart19 infusion

    The main treatment involves the infusion of TranspoCART19 cells, which are genetically modified T lymphocytes designed to target specific cancer cells.

    This infusion is administered intravenously, and the process is monitored closely to ensure safety and effectiveness.

  5. Step 5

    Monitoring and follow-up

    After the infusion, regular monitoring is conducted to assess the body's response to the treatment. This includes frequent blood tests and health evaluations.

    Follow-up visits are scheduled weekly for the first month, then monthly for the first six months, and quarterly thereafter until two years post-infusion.

  6. Step 6

    Quality of life assessment

    Throughout the trial, quality of life is assessed using a questionnaire. This helps to understand the impact of the treatment on daily living.

    Assessments are conducted before treatment, and at three months, six months, and one year after the infusion.

Who can join the trial?

12 criteria

  • Patients must have been diagnosed with relapsed or refractory B-cell lymphoma. This means the cancer has returned or did not respond to previous treatments.
  • Patients with diffuse large B-cell lymphoma must have had the disease return or not respond after at least two different treatments and are not candidates for or have relapsed after a specific type of stem cell transplant.
  • Patients with primary diffuse large B-cell CNS lymphoma must have had the disease return or not respond after one or more treatments, including a high-dose methotrexate regimen.
  • Patients with refractory mantle cell lymphoma must have had the disease return or not respond after at least one treatment, which includes specific drugs like anthracycline, bendamustine, anti-CD20 monoclonal antibody, and BTKi treatments such as ibrutinib or acalabrutinib.
  • Patients with follicular lymphoma (grades 1, 2, or 3a) must have had the disease confirmed in the last six months and have had it return or not respond after at least two treatments, one of which included an anti-CD20 drug like rituximab or obinutuzumab.
  • Patients with marginal lymphoma must have had the disease confirmed in the last six months and have had it return or not respond after at least two treatments, one of which included an anti-CD20 drug and an alkylating agent, or have relapsed after a specific type of transplant.
  • Patients must be between 18 and 80 years old.
  • Patients must have a functional status of ECOG 0-1, which means they are fully active or have some symptoms but do not need bed rest. Patients with ECOG 2, who are unable to work but can take care of themselves, may be included if their condition is due to blood-related disease.
  • Patients must have an adequate bone marrow reserve, meaning their bone marrow can produce enough blood cells.
  • Patients must have a life expectancy of at least 2 months.
  • Patients must have adequate venous access for a procedure called lymphapheresis, which involves collecting white blood cells, and must not have any conditions that prevent this procedure.
  • Patients or their legal guardians must sign an informed consent, agreeing to participate in the study after understanding its details.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than relapsed or refractory B-cell lymphoma cannot participate. Relapsed means the cancer has come back after treatment, and refractory means the cancer did not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study cannot participate.
  • Patients who have had another cancer treatment recently that might interfere with the study cannot participate.
  • Patients who have an active infection that requires treatment cannot participate.
  • Patients who have a known allergy to any component of the study treatment cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have a history of certain heart conditions cannot participate.
  • Patients who have a history of certain lung conditions cannot participate.
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Investigated drugs

TranspoCART19 is a type of therapy that uses your own immune cells to fight cancer. In this treatment, doctors take a type of white blood cell called T lymphocytes from your blood. These cells are then expanded and genetically modified in a lab using a special technique called Sleeping Beauty transposons. This modification helps the cells recognize and attack cancer cells. The modified cells are designed to target a specific protein called CD19, which is found on the surface of certain cancer cells. Once the cells are ready, they are infused back into your body to help fight the cancer. This therapy is being tested in patients with a type of cancer called B-cell lymphoma that has come back or has not responded to other treatments.

What is already known about the treatment

TranspoCART19 – This medication is administered through an infusion, where a patient's own T lymphocytes are collected, expanded, and genetically modified to target cancer cells. Currently, it is being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory B-cell lymphoma, a type of blood cancer. The main therapeutic use of TranspoCART19 is to help the immune system recognize and attack cancer cells. At the molecular level, it works by using a special receptor that targets a protein called CD19 on the surface of cancer cells, helping the immune cells to destroy them. TranspoCART19 falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

Relapsed or refractory B-cell lymphoma – This is a type of cancer that affects B-cells, which are a type of white blood cell responsible for producing antibodies. In this condition, the lymphoma either returns after treatment (relapsed) or does not respond to treatment (refractory). The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, bone marrow, and other organs. As it progresses, patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly while others may progress more rapidly. The behavior of the lymphoma cells and their response to treatment can influence the course of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514544-90-00Estimated enrolment27 patientsSponsorFundacion De Investigacion Biomedica De Salamanca

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