Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma

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

NCT07300683•University College, London

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•ECOG performance score \>2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged \<10 years old)
•Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
•Active CNS involvement of disease
•Active hepatitis B, C or HIV infection
•Oxygen saturation ≤90% on air
•Bilirubin \>3 x upper limit of normal
•GFR \<30 ml/min
•Cardiac dysfunction
•Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
•Known allergy to any component of the ATIMP
+4 more criteria

Locations (1)

University College London Hospitals

London, United Kingdom

Key Dates

Start Date

November 11, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2042

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

T Cell Acute Lymphoblastic LeukemiaT Cell Lymphoblastic Lymphoma

Interventions

CARCCR9 T cells

BIOLOGICAL

Contacts

FRACTALL Trial Manager

CONTACT

+44 (0)20 76705748 ctc.fractall@ucl.ac.uk

Newly-diagnosed Pediatric T-cell ALL Protocol

NCT06855810

Acute Lymphoblastic LeukemiaChildhood Leukemia, Acute Lymphoblastic+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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