Long‑Term Safety Study of S68587 in Patients with Advanced Lymphoid Leukemia Previously Treated with the Therapy

3 1 1

What is this study about?

The study involves patients who have a type of blood cancer called Advanced lymphoid leukemia. In earlier treatment they received a therapy known as UCART19, which is made from donor immune cells that have been engineered to carry a chimeric antigen receptor. This laboratory‑made protein helps the cells recognize and attack cancer cells that display a marker called CD19, a feature found on many lymphoid cancers. The engineered cells are given through an IV infusion, similar to a standard blood transfusion.

The purpose of the study is to evaluate the long‑term safety of these patients. After the previous infusion, participants will have regular visits for up to several years, during which doctors will check for any health problems, record any side effects, and monitor growth and puberty in children. Simple tests such as blood work and routine imaging will be used to watch for signs of disease return or other issues, and the information collected will help determine how safe the therapy is over the long term.

1 enrollment and consent

after joining the study you sign a consent form that explains the purpose of the follow‑up and the information that will be collected.

your personal and medical information is entered into the study record and a schedule of future visits is created.

2 baseline assessment

a baseline visit is performed to record your current health status, including a physical examination and a review of your medical history.

blood samples are taken to measure the level of the ucart19 transgene and to check routine laboratory values.

if a bone‑marrow sample is part of your routine care, it may be collected at this time for optional analysis.

for paediatric participants a growth assessment is done to establish a reference for future comparison.

3 administration of ucart19 (previous infusion)

the study follows patients who have already received a single intravenous infusion of the cell product s68587.

the product is supplied as a suspension for infusion with concentrations such as 20 megacells per milliliter, 15 megacells per milliliter, 6 megacells per milliliter, or 0.6 megacells per milliliter.

the dose is expressed in the number of cells rather than milligrams, and the infusion is given only once.

4 regular follow‑up visits (first 12 months)

you attend scheduled clinic visits, typically every month, for the first year after the last ucart19 infusion.

at each visit you report any side effects, which are called adverse events, and the study team records their duration and outcome.

blood tests are repeated to monitor the level of the transgene and other safety laboratory values.

paediatric participants receive growth monitoring at each visit to assess any impact on height and puberty.

any serious side effect that could lead to death is documented and followed closely.

5 long‑term monitoring (beyond 12 months until study end)

after the first year, visits continue at longer intervals, such as every six months, until the planned study end date in 2035.

the same assessments are performed: reporting of adverse events, blood sampling for transgene levels, and optional bone‑marrow sampling if it is part of routine care.

additional evaluations include checking for disease relapse or progression, and recording overall survival information.

paediatric growth assessments continue as needed.

6 final study visit and data closure

at the final visit the study team collects the last set of safety and laboratory data.

all information collected during the study is reviewed and entered into the study database for final analysis.

Who Can Join the Study?

  • You must give written informed consent (a signed agreement that you understand the study) before any study procedures are done. This can be signed by you, a parent, or a legal representative.
  • You must have already received the treatment called UCART19 in a previous trial or special access program, and you must have either finished that study or stopped it early.
  • If you are a female who could become pregnant, or a male who has a partner who could become pregnant, you and your partner must use an effective birth control method for at least 12 months after the last dose of UCART19.
  • You must have a diagnosis of advanced lymphoid leukemia (a type of blood cancer that affects certain white blood cells).
  • You can be male or female, and the study includes people of various ages, including children and adolescents.

Who Cannot Join the Study?

  • There are no exclusion criteria; this means that no specific medical conditions or factors prevent a patient with advanced lymphoid leukemia from taking part in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

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 edited. These cells are engineered to carry a chimeric antigen receptor (CAR) that recognizes the CD19 protein found on many B‑cell leukemias. In addition, the genes TRAC and CD52 are disabled to reduce the risk of the cells attacking the patient’s own tissues and to help the cells stay active longer. The product is supplied as a suspension that is given through an intravenous infusion. In this long‑term follow‑up study, patients who previously received this therapy are being monitored to see if any safety issues appear over time.

Investigated diseases:

Acute lymphoblastic leukemia – Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that begins in early‑stage lymphoid cells. The abnormal cells multiply quickly and replace normal blood‑forming cells. As the disease advances, the number of leukemic cells in the blood and marrow rises, causing worsening blood counts. The leukemia can spread to other organs such as the liver, spleen, and central nervous system. Over time, the disease may become resistant to standard therapies, leading to further increase of malignant cells.

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

Other Trials to Consider

  • Study of Ruxolitinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with IL-7R/JAK-STAT Pathway Mutations

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +5
  • Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Bulgaria Czechia Denmark Estonia +11