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

NCT ID: NCT07300683

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-11

Study Completion Date

2042-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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T Cell Acute Lymphoblastic Leukemia T Cell Lymphoblastic Lymphoma

Keywords

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FRACTALL Fratricide-Resistant CCR9 CAR T cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a multi-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) for patients with high-risk, relapsed/refractory (r/r) T-ALL/T-LBL.

The trial will have 2 cohorts: Adult (≥18 years old) and Paediatric (\<18 years old).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous anti-CCR9 CAR T cells

Patients will receive autologous anti-CCR9 CAR T cells intravenously.

Group Type EXPERIMENTAL

CARCCR9 T cells

Intervention Type BIOLOGICAL

Anti-CCR9 CAR T cells

Interventions

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CARCCR9 T cells

Anti-CCR9 CAR T cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
* 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
* Fulminant or rapidly progressive disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital Charity

UNKNOWN

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University College London Hospitals

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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FRACTALL Trial Manager

Role: CONTACT

Phone: +44 (0)20 76705748

Email: [email protected]

Other Identifiers

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2022-003497-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN15341827

Identifier Type: OTHER

Identifier Source: secondary_id

UCL/150854

Identifier Type: -

Identifier Source: org_study_id