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Study on CD19+ Lymphoid Disease Using Genetically Modified T Cells for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

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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 treating patients with certain types of blood cancers, specifically Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin's Lymphoma (NHL), which have either returned after treatment or have not responded to previous treatments. The study uses a special type of treatment called CD19.CAR T cells, which involves modifying a patient's own immune cells, known as T lymphocytes, to better recognize and attack cancer cells. These modified cells are then given back to the patient through an infusion, which is a way of delivering medication directly into the bloodstream.

The purpose of the study is to evaluate the safety and feasibility of using these modified T cells in patients with these challenging blood cancers. The study will involve gradually increasing the dose of these cells to find the most effective and safe amount. Patients will receive the treatment and be monitored closely to see how their bodies respond and to check for any side effects. The study aims to understand how well the treatment works in reducing the cancer and improving patient outcomes.

Throughout the study, researchers will assess various aspects, such as the survival and function of the CAR T cells in the body, the reduction of cancer burden, and the overall response of the disease to the treatment. The study will also look at how long the response lasts and the overall survival of patients after receiving the treatment. This research is important for developing new and effective treatments for patients with these difficult-to-treat blood cancers.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of disease, and health status.

    The study involves patients with certain types of blood cancers, including acute lymphoblastic leukemia and non-Hodgkin's lymphoma.

  2. Step 2

    Leukapheresis

    A procedure called leukapheresis is performed to collect white blood cells from the bloodstream.

    These cells are used to create the CD19.CAR T cells for the treatment.

  3. Step 3

    Cell modification

    The collected T cells are genetically modified in a laboratory to target the CD19 molecule on cancer cells.

    This process involves using a retroviral vector to introduce new genetic material into the T cells.

  4. Step 4

    Preparation for infusion

    Before receiving the modified T cells, a conditioning treatment may be administered to prepare the body.

    This step helps the body accept the new cells and can involve chemotherapy.

  5. Step 5

    Infusion of CD19.CAR T cells

    The modified T cells, now called CD19.CAR T cells, are infused back into the body through an intravenous solution.

    The infusion is carefully monitored to ensure safety and effectiveness.

  6. Step 6

    Monitoring and follow-up

    After the infusion, regular monitoring is conducted to assess the response to the treatment and any side effects.

    The study evaluates the safety and effectiveness of the treatment over time, including the reduction of cancer cells and overall health improvements.

  7. Step 7

    End of study

    The study is expected to conclude by the end of 2027.

    Final assessments are made to determine the long-term outcomes of the treatment.

Who can join the trial?

10 criteria

  • For adults (18 years and older): Must have a confirmed diagnosis of **CD19+** diseases like **ALL** (Acute Lymphoblastic Leukemia), **CLL** (Chronic Lymphocytic Leukemia), **DLBCL** (Diffuse Large B-Cell Lymphoma), **FL** (Follicular Lymphoma), or **MCL** (Mantle Cell Lymphoma).
  • For adults: The disease must have returned or not responded to treatment, including cases with very small amounts of disease left after treatment.
  • For adults: Kidney function must be within a certain range, with a **serum creatinine** level no more than twice the normal limit or an **eGFR** (estimated Glomerular Filtration Rate) of at least 30 mL/min/1.73 m².
  • For adults: Must have a certain number of **lymphocytes** (a type of white blood cell) in the blood, at least 100 per cubic millimeter.
  • For children and teenagers (older than 3 years but younger than 18 years): Must have a confirmed diagnosis of **CD19+ ALL**, with the disease having returned or not responded to treatment.
  • For children and teenagers: Must have a measurable amount of disease at the time of joining the study.
  • For children and teenagers: Must have a life expectancy of at least 12 weeks.
  • For children and teenagers: Must be able to perform daily activities to a certain level, measured by a performance status score.
  • For children and teenagers: Kidney function must be defined by a **serum creatinine-clearance** of at least 30 mL/min/1.73 m².
  • For children and teenagers: Must have a certain number of **lymphocytes** in the blood, at least 100 per cubic millimeter.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than the ones being studied cannot participate.
  • Patients who have not experienced a return or resistance to treatment of their cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.
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Investigated drugs

RV-SFG.CD19.CD28.4-BBzeta Retroviral Vector is used to modify the patient's own T lymphocytes. This genetic modification allows the T cells to express a special receptor called a CAR, which helps them recognize and attack cancer cells that have the CD19 molecule on their surface. This therapy is being tested for its safety and effectiveness in treating certain types of lymphoid diseases that have not responded to other treatments.

What is already known about the treatment

RV-SFG.CD19.CD28.4-BBzeta Retroviral Vector – This medication is administered through infusion, where genetically modified T lymphocytes are introduced into the patient's bloodstream. It is currently in Phase I/II clinical trials, focusing on its safety and effectiveness for treating certain types of blood cancers. The main therapeutic indications include relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma. At the molecular level, the medication works by modifying T cells to express a chimeric antigen receptor (CAR) that targets the CD19 protein on cancer cells, enhancing the immune system's ability to attack these cells. It falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

  • Acute Lymphoblastic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. It progresses rapidly, leading to a decrease in the number of healthy blood cells, which can cause symptoms like fatigue, frequent infections, and easy bruising or bleeding. The disease is most common in children but can also occur in adults. As the leukemia cells multiply, they can spread to other parts of the body, including the lymph nodes, liver, and spleen.

  • Non-Hodgkin's Lymphoma

    This is a group of blood cancers that develop in the lymphatic system from cells called lymphocytes, a type of white blood cell. It can be either slow-growing or aggressive, with symptoms that may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can start in different parts of the body, such as the lymph nodes, spleen, or bone marrow, and can spread to other organs. The progression and symptoms can vary widely depending on the specific type and stage of the lymphoma.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516832-82-00Estimated enrolment63 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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