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

NCT07300683 | Recruiting Phase 1 DMC

• 3 other identifiers: UCL/1508542022-003497-23ISRCTN15341827
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T Cell Acute Lymphoblastic Leukemia; T Cell Lymphoblastic Lymphoma

Keywords

FRACTALL; Fratricide-Resistant; CCR9; CAR T cells

Outcome Measures

Primary Outcomes (2)

• Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.

  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)

  Incidence of grade 3-5 toxicity causally related to the ATIMP.

  From CAR T cells infusion until 28 days post infusion

Secondary Outcomes (7)

• Persistence of CARCCR9 T cells

  From CAR T cells infusion until 2 years post infusion

• Expansion of CARCCR9 T cells

  From CAR T cells infusion until 2 years post infusion

• Potential efficacy of CARCCR9 T cells

  At 1 and 2 years post CAR T cells infusion

• Potential efficacy of CARCCR9 T cells

  At 1 and 2 years post CAR T cells infusion

• Time to 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.

Study Arms (1)

Autologous anti-CCR9 CAR T cells

EXPERIMENTAL

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

Biological: CARCCR9 T cells

Interventions

CARCCR9 T cells BIOLOGICAL

Anti-CCR9 CAR T cells

Autologous anti-CCR9 CAR T cells

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Council: collaborator
• University College, London: lead
• Great Ormond Street Hospital Charity: collaborator

Study Sites (1)

University College London Hospitals

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

FRACTALL Trial Manager

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: December 24, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2042
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

GB (1)