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Long-Term Follow-Up Study for Patients Treated with CAR T-Cell Therapy Using PHE885, YTB323, and Tisagenlecleucel

Verified siteRegistered drugNo placebo
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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 the long-term follow-up of patients who have been treated with a type of therapy known as CAR T-cell therapy. This therapy involves using a patient's own immune cells, called T-cells, which are modified to better recognize and attack cancer cells. The study includes patients who have received this treatment for various conditions, using products developed by Novartis or Penn. The main purpose of the study is to observe and describe any delayed side effects that might be related to the previous CAR T-cell therapy.

The study involves several treatments, including PHE885, YTB323, and Tisagenlecleucel. These treatments are given as a dispersion for infusion, which means they are administered directly into the bloodstream through an intravenous infusion. PHE885 uses a patient's own T-cells that are engineered to target a specific protein on cancer cells called the B cell maturation antigen. YTB323 involves T-cells that are modified to target another protein known as CD19. Tisagenlecleucel is also a type of CAR T-cell therapy that targets cancer cells using a similar approach.

Throughout the study, researchers will monitor patients for any new health issues that may arise after receiving CAR T-cell therapy. This includes checking for new cancers, serious infections, neurological disorders, autoimmune conditions, and blood disorders. The study will also track the presence of the modified T-cells in the blood over time and observe any changes in the patient's health status, such as relapse or progression of their condition. The study aims to provide valuable information on the long-term safety and effects of CAR T-cell therapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the study

    Participation begins after receiving CAR-T therapy in a Novartis or Penn sponsored trial or managed access program.

    Informed consent is required before joining the study.

  2. Step 2

    Monitoring for adverse events

    The study aims to observe any delayed adverse events related to previous CAR T-cell therapy.

    These events include new secondary cancers, serious infections, neurological disorders, autoimmune disorders, and blood disorders.

  3. Step 3

    Blood tests

    Regular blood tests are conducted to detect CAR transgene levels and RCL (replication-competent lentivirus) using specific PCR methods.

    These tests occur at pre-specified intervals throughout the study.

  4. Step 4

    Health assessments

    Health assessments include monitoring for relapse or disease progression, and recording any incidence of death.

    Additional evaluations involve measuring B and T lymphocyte counts, as well as physical assessments like height, weight, and other developmental indicators.

  5. Step 5

    Study duration

    The study is expected to continue until June 2036.

    Participants will be monitored throughout this period to gather comprehensive data on long-term effects.

Who can join the trial?

6 criteria

  • Patients must have received CAR-T therapy. This is a type of treatment where a patient's own immune cells are changed in a lab to attack cancer cells.
  • The CAR-T therapy must have been part of a trial or program sponsored by Novartis or Penn, either as the only treatment or combined with other treatments.
  • Patients must agree to participate in the study by providing informed consent. This means they understand the study and agree to take part.
  • Both male and female patients are eligible to participate.
  • Patients of various age groups can participate, including children, teenagers, and adults.
  • The study includes patients who might be considered vulnerable, meaning they may need extra care or protection.

Who cannot join the trial?

1 criterion

  • Patients who have been treated with Novartis or Penn CAR-T for any reason cannot participate.
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Investigated drugs

Lentiviral-Based CAR T-Cell Therapy is a type of treatment that uses a patient's own immune cells, which are modified in the laboratory to better recognize and attack cancer cells. This therapy involves collecting T-cells from the patient, altering them with a lentivirus to express a chimeric antigen receptor (CAR) on their surface, and then infusing them back into the patient. The CAR helps the T-cells to identify and destroy cancer cells more effectively. This clinical trial is focused on the long-term follow-up of patients who have received this therapy to monitor for any delayed adverse effects that might occur after the treatment.

What is already known about the treatment

CAR T-Cell Therapy – This treatment is administered through an infusion, where modified T-cells are introduced into the patient's bloodstream. It is currently a significant focus in medical research, particularly for its potential in treating certain types of cancer. The main therapeutic indication is for patients who have previously received CAR T-cell therapy, often for conditions like leukemia or lymphoma. At the molecular level, the therapy involves genetically modifying T-cells to better recognize and attack cancer cells. It falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

  • Secondary Malignancies

    These are new cancers that occur in patients who have previously been treated for another cancer. They can develop months or even years after the initial cancer treatment. The risk of secondary malignancies can be influenced by the type of treatment received, such as chemotherapy or radiation. These malignancies can vary in type and severity, and their development is often monitored in patients with a history of cancer treatment.

  • Serious Infections

    These are infections that can cause significant health problems and may require medical intervention. They can occur when the immune system is weakened, such as after certain medical treatments like CAR T-cell therapy. Serious infections can affect various parts of the body, including the lungs, skin, and bloodstream. The progression of these infections can be rapid, necessitating prompt medical attention.

  • Serious Neurologic Disorders

    These are conditions that affect the nervous system, potentially leading to symptoms such as seizures, confusion, or difficulty with movement. They can arise as a complication of medical treatments or due to other underlying health issues. The progression of neurologic disorders can vary widely, with some conditions developing suddenly and others worsening over time.

  • Rheumatologic or Autoimmune Disorders

    These disorders occur when the immune system mistakenly attacks the body's own tissues, leading to inflammation and damage. They can affect joints, skin, and other organs, causing symptoms like pain, swelling, and fatigue. The progression of these disorders can be unpredictable, with periods of flare-ups and remission.

  • Hematologic Disorders

    These are conditions that affect the blood and its components, such as red blood cells, white blood cells, and platelets. They can lead to symptoms like fatigue, bleeding, or increased risk of infections. Hematologic disorders can be caused by genetic factors, environmental exposures, or as a side effect of medical treatments.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508128-37-00Protocol codeCCTL019A2205BEstimated enrolment1 174 patientsSponsorNovartis Pharma Services AG

sourced from the EU Clinical Trials Register and site verification

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