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Taking people in United KingdomPhase 1

Tests patient's own CCR9-targeted CAR T cells for T cell leukaemia and lymphoma

Tests CCR9-targeted CAR T cells made from patients' own cells in T cell leukaemia.

Plain-language title generated from the registry record
Registry title: Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma

Key facts

Where
London, United KingdomSee the site
Phase
Phase 1

Where in United Kingdom

  • University College London HospitalsLondon, United KingdomTaking people

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Trial details

Who runs it
University College, London
Trial code
NCT07300683
Record updated
24 December 2025
Original description
The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.Read full original descriptionShow less

Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma

The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.

Participants will:

* have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory. * be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells. * be given the CAR T cells into their vein. * stay in the hospital for a minimum of 2 weeks to be closely monitored * following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years) * during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.

Inclusion: Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy; CCR9-positive disease as assessed by flow cytometry; T-LBL patients only: Patients must have measurable disease; Agreement to have a pregnancy test, use adequate contraception (if applicable); Written informed consent.

Exclusion: Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids; Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued; Active CNS involvement of disease; Active hepatitis B, C or HIV infection; Cardiac dysfunction; Known allergy to any component of the ATIMP; Fulminant or rapidly progressive disease; Bilirubin >3 x upper limit of normal; GFR <30 ml/min; ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old); Oxygen saturation ≤90% on air; Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC; Women who are pregnant or breastfeeding; Life expectancy <3 months.

ClinicalTrials.gov NCT07300683