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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
03.04.2026

Trial locations

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.

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 ID:
2026-526212-37-00
Protocol code:
CL1-68587-003
NCT ID:
NCT02735083
Trial Phase:
Therapeutic confirmatory (Phase III)

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