CAReLEMAN Study – A New Cell Therapy for Children and Young Adults with Leukemia

The CAReLEMAN study, conducted at the Lausanne University Hospital (CHUV) in Switzerland in collaboration with Leman BioTech, is exploring a new and promising treatment for children and young adults with acute lymphoblastic leukemia (ALL) who have relapsed after standard therapy. ALL is the most common type of blood cancer in children. Thanks to advances in treatment, most patients can be cured — but for those whose leukemia comes back, options remain limited and often involve very intensive chemotherapy or bone marrow transplants.

This study is testing an innovative approach called IL-10 CAR-T anti-CD19 therapy. CAR-T cells are special immune cells taken from the patient’s blood and modified in the laboratory to recognize and attack cancer cells. In this new version, researchers have added a molecule called interleukin-10 (IL-10) to help keep the cells strong and active for a longer period of time, making them potentially more effective against leukemia (Prof. Li Tang, EPFL).

The CAReLEMAN trial will first check that this new therapy is safe and feasible (phase I), and then evaluate whether it is effective in controlling the disease (phase II). The study includes two groups of patients: those who have never received CAR-T treatment before, and those whose leukemia has returned after a previous standard CAR-T therapy.

Early results from studies with adults have shown low toxicity and very high response rates, even at extremely low doses (Xu Q et al., IL-10-expressing, anti-CD19 CAR T cells for patients with relapsed or refractory B-cell acute lymphoblastic leukaemia: an open-label, single-arm, phase 1 study. Lancet Haematol. 2025). The CAReLEMAN study aims to bring these promising results to young patients, offering a gentler, more precise, and more durable treatment option that could reduce the long-term side effects seen with traditional therapies.

If successful, this study could represent an important step toward safer personalized treatments for children and young adults with difficult-to-treat leukemia — and new hope for their families.

A phase I clinical trial assessing prophylactic infusion of donor CD45RA-negative memory/effector T cells into patients transplanted with hematopoietic stem cells from haploidentical donors after reduced intensity conditioning

Many patients transplanted with hematopoietic stem cells receive prophylactic donor lymphocyte infusions (DLI) to lower the risk of relapse and restore immunity. This life-saving therapy is not available to patients transplanted with grafts from highly incompatible donors, because the risk of graft-versus-host disease (GvHD) would be too high.

Our project is a phase I study (12 patients) to test feasibility and safety of infusing escalating doses of DLI from which the bulk of alloreactive T cells that reside mainly in the CD45RA-positive (naïve) T cell population has been removed through CliniMACS® technology.

Our cohort of patients will be compared prospectively with the control group of patients transplanted at the University Hospitals of Basel and Zurich with the same transplant protocol, but without infusion of CD45RA-negative DLI.