NCT07300683RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 11 Nov 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- University College, London
- NCT number
- NCT07300683
- EudraCT number
- 2022-003497-23
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 11 Nov 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
- Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
Other illness
- Active CNS involvement of disease
- Active hepatitis B, C or HIV infection
- Cardiac dysfunction
- Known allergy to any component of the ATIMP
- Fulminant or rapidly progressive disease
Lab values
- Bilirubin \>3 x upper limit of normal
- GFR \<30 ml/min
Age
- ECOG performance score \>2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged \<10 years old)
Other
- Oxygen saturation ≤90% on air
- 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
Who 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 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.