Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma (FRACTALL)

December 17, 2025 updated by: University College, London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • University College London Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous anti-CCR9 CAR T cells
Patients will receive autologous anti-CCR9 CAR T cells intravenously.
Biological: CARCCR9 T cells
Anti-CCR9 CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
Time Frame: 2 years
To determine the feasibility of semi-automated autologous CARCCR9 T cells manufacture in patients with r/r T-ALL/T-LBL, in the setting of a Phase I trial.
2 years
Incidence of treatment-related adverse events (safety and tolerability)
Time Frame: From CAR T cells infusion until 28 days post infusion
Incidence of grade 3-5 toxicity causally related to the ATIMP.
From CAR T cells infusion until 28 days post infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of CARCCR9 T cells
Time Frame: From CAR T cells infusion until 2 years post infusion
Persistence of circulating CARCCR9 T cells in peripheral blood
From CAR T cells infusion until 2 years post infusion
Expansion of CARCCR9 T cells
Time Frame: From CAR T cells infusion until 2 years post infusion
Frequency of circulating CARCCR9 T cells in peripheral blood
From CAR T cells infusion until 2 years post infusion
Potential efficacy of CARCCR9 T cells
Time Frame: At 1 and 2 years post CAR T cells infusion
Proportion of responders
At 1 and 2 years post CAR T cells infusion
Potential efficacy of CARCCR9 T cells
Time Frame: At 1 and 2 years post CAR T cells infusion
Depth of response
At 1 and 2 years post CAR T cells infusion
Time to disease progression
Time Frame: From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.
Length of time from CAR T cells infusion until disease progression
From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.
Event free survival
Time Frame: From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.
Length of time after a patient receives the CAR T cells and remain free from disease progression, recurrence, or death from any cause.
From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.
Overall survival
Time Frame: From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.
Length of time from the CAR T cells infusion until death, regardless of the cause
From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Medical Research Council
Great Ormond Street Hospital Charity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2042

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL/150854
  • 2022-003497-23 (EudraCT Number)
  • ISRCTN15341827 (Other Identifier: ISRCTN)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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