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Long‑term safety study of S68587 (allogeneic CD19 CAR T‑cells with TRAC and CD52 disruption) in patients with advanced lymphoid leukemia

InvestigationalNo placebo
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What is this trial about?

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

The study follows patients with Advanced lymphoid leukemia who have previously received an infusion of the experimental cell therapy called UCART19. This therapy consists of donor‑derived T cells that have been engineered to carry a CAR that recognizes the protein CD19 on the surface of the cancer cells. The cells are also modified by removing the genes TRAC and CD52 to reduce the risk of the immune system attacking the infused cells.

The purpose of the study is to evaluate the long‑term safety of the therapy. After the original infusion, participants will attend regular clinic visits over several years during which doctors will check for any health problems, record any side effects, and collect blood samples. Children will have additional assessments to see whether growth or puberty are affected.

During follow‑up, routine tests may include blood work, imaging scans if needed for clinical care, and, when part of standard care, a bone‑marrow sample to look for the engineered cells. All information gathered will be used only to understand how the therapy behaves over time and to identify any late‑appearing safety issues.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Ucart19 infusion

    You receive an intravenous infusion of UCART19, an allogeneic engineered t‑cell product that expresses a chimeric antigen receptor targeting cd19. the infusion is administered as a suspension for infusion through a vein.

    The product is supplied in concentrations of 0.6, 6, 15, or 20 mega cells per millilitre. the exact concentration and volume are defined by the study protocol. the dose is recorded as 0 mg because the therapy is measured in cell numbers rather than weight.

  2. Step 2

    Initial safety monitoring

    After the infusion you remain in the clinic for observation. vital signs and any immediate reactions are recorded.

    Blood samples are taken to measure the presence of the cd19‑car transgene using quantitative pcr (a laboratory test that counts copies of the engineered gene).

  3. Step 3

    Regular follow‑up visits (first 12 months)

    You attend scheduled visits for at least twelve months after the last infusion. at each visit health status, adverse events, and any new symptoms are documented.

    Laboratory tests, including the cd19‑car transgene measurement, are performed. if a bone‑marrow sample is collected as part of routine disease care, it may also be tested for the transgene.

    Any adverse events of special interest are specifically recorded and evaluated.

  4. Step 4

    Long‑term safety assessment

    The study continues to collect safety information until the planned end date of the trial (1 june 2035).

    Your overall survival, disease progression, and any need for additional treatments such as allogeneic stem‑cell transplantation are monitored.

    For paediatric patients, growth measurements and puberty development are assessed periodically to detect any impact of the therapy.

Who can join the trial?

4 criteria

  • You must sign a written informed consent form (a document that shows you agree to take part) before any study procedures are done.
  • You must have already received the treatment called UCART19 in a previous trial or through a special access program (sometimes called “compassionate use”), and you either finished that study or stopped it early.
  • If you are a woman who could become pregnant, or a man whose partner could become pregnant, you and your partner must use an effective method of birth control for at least 12 months after the last dose of UCART19.
  • Both men and women can join the study, and patients of any age (children, teenagers, and adults) are eligible.

Who cannot join the trial?

1 criterion

  • No exclusion criteria for this study, meaning there are no listed reasons that would automatically prevent someone from joining.
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Investigated drugs

S68587 is a cell‑based therapy made from donor T‑cells that have been genetically changed in the lab. These T‑cells carry a special receptor called a chimeric antigen receptor (CAR) that recognizes CD19, a protein found on the surface of many B‑cell leukemias. By targeting CD19, the engineered cells can find and kill the leukemia cells in the patient’s body. In addition, the therapy disables two genes, TRAC and CD52, in the T‑cells. This helps reduce the chance that the patient’s immune system will reject the donor cells and improves the safety of the treatment. The product is given to patients through an intravenous infusion, where the cells travel through the bloodstream to seek out and attack cancer cells. The trial is watching these patients over a long period to see how safe the therapy is after they have already received it.

What is already known about the treatment

  • S68587 - 20 megaCells/ml

    The product is a suspension for infusion that is administered intravenously, meaning it is poured into a vein through a drip. It is an investigational cell therapy that is still being studied in clinical trials and has not received market approval. The treatment is intended for patients with advanced lymphoid leukemia that expresses the CD19 marker. It works by using donor T‑cells that have been engineered to carry a chimeric antigen receptor (CAR) that binds CD19, and the genes TRAC and CD52 are removed to improve safety; this directs the cells to find and kill the cancer cells. The medication belongs to the class of CAR‑T cell therapies, a type of gene‑modified cellular immunotherapy.

  • S68587 - 15 megaCells/ml

    This medicine is supplied as a liquid suspension that is given by intravenous infusion, delivering the product directly into the bloodstream. It remains an experimental therapy under clinical investigation and is not yet approved for general use. The main use is for treating advanced lymphoid leukemia that shows the CD19 protein on its surface. The engineered T‑cells carry a CAR that recognizes CD19 and, with the TRAC and CD52 genes knocked out, they can safely locate and destroy the leukemia cells. It is classified as a CAR‑T cell immunotherapy, a form of cell‑based gene therapy.

  • S68587 - 6 megaCells/ml

    The drug is provided as a suspension that is infused intravenously, allowing the cells to travel through the blood to reach the cancer. It is currently in the research stage, being evaluated in clinical trials and has not been approved for routine treatment. Its purpose is to treat patients with advanced lymphoid leukemia that expresses CD19. The therapy uses donor T‑cells edited to express a CD19‑targeting CAR and lacking TRAC and CD52, enabling the cells to seek out and kill the leukemia cells. This product falls under the CAR‑T cell therapy category, a type of genetically modified cellular medicine.

  • S68587 - 0.6 megaCells/ml

    Administered as an intravenous infusion of a cell suspension, the medication is delivered directly into a vein. It is an experimental, gene‑engineered cell therapy still being tested in clinical studies and has no commercial approval. The indication is advanced lymphoid leukemia that carries the CD19 antigen. The therapy’s T‑cells are equipped with a CAR that binds CD19 and have the TRAC and CD52 genes removed, allowing them to specifically attack the cancer cells while reducing the risk of immune reactions. It is classified as a CAR‑T cell immunotherapy, a form of cellular gene therapy.

Investigated diseases

Acute lymphoblastic leukemia - Acute lymphoblastic leukemia is a cancer that starts in the bone marrow and produces large numbers of immature lymphoid cells. These abnormal cells crowd out normal blood‑forming cells, reducing red cells, platelets, and healthy white cells. Over weeks to months, the disease can spread from the marrow into the bloodstream and infiltrate organs such as the spleen, liver, and central nervous system. As the number of leukemia cells grows, symptoms such as fatigue, bruising, and infections may become more noticeable. The condition is considered advanced when a high proportion of marrow cells are leukemic and the disease has extended beyond the marrow.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526212-37-00Protocol codeCL1-68587-003Estimated enrolment30 patientsSponsorInstitut De Recherches Internationales Servier IRIS

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