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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: CARCCR9 T cells (biological)
How long the study runs: Study runs about 205 months (dates as stated)
About the drug or intervention: CARCCR9 T cells — biological: Anti-CCR9 CAR T cells
Patient visit burden: "* 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." (as stated by sponsor)

Type of study: Testing a treatment
Ages: Not specified
Who: All
Number of participants: 24
Started: 2025-11-11
Last checked: 2025-11

Plain English Summary

What is this study?

• Testing a new treatment for t cell acute lymphoblastic leukemia
• Phase1 - 24 participants
• 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

Who can take part?

• Adults
• Diagnosed with t cell acute lymphoblastic leukemia

Where?

• London - University College London Hospitals

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

T Cell Acute Lymphoblastic LeukemiaT Cell Lymphoblastic Lymphoma

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: Not specified
Who can join: All genders

Treatment history

Treatments you must have had:

✓ measurable disease

What the study is looking for

✓Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (\<18 years old) standard prior...
✓CCR9-positive disease as assessed by flow cytometry
✓T-LBL patients only: Patients must have cancer that can be measured on scans
✓Agreement to have a pregnancy test, use adequate contraception (if applicable)
✓Written agreement to take part

Who cannot take part

✗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...
✗Active CNS involvement of disease
✗Active hepatitis B, C or HIV infection
✗Oxygen saturation ≤90% on air

See the full criteria

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

Where Is This Study? (1 UK site)

University College London Hospitals

London, United Kingdom

Recruiting

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net 020 3447 9825

How to Get in Touch

FRACTALL Trial Manager

Sponsor contact

CONTACT

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

Data sourced from ClinicalTrials.gov · Last verified: 2025-11