Actively Recruiting
Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma
Led by University College, London · Updated on 2025-12-24
24
Participants Needed
1
Research Sites
889 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
G
Great Ormond Street Hospital Charity
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory T-ALL or T-LBL after at least one prior combination therapy if 18 years or older, or two prior therapies if under 18 years
- Disease must be CCR9-positive as shown by flow cytometry
- T-LBL patients must have measurable disease
- Agreement to pregnancy testing and use of effective contraception if applicable
- Written informed consent provided
You will not qualify if you...
- ECOG performance score greater than 2 for patients aged 10 years or older, or Lansky score 50% or less for patients under 10 years
- For stem cell transplant patients: active significant acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease needing immunosuppressive therapy or steroids
- Active central nervous system involvement of disease
- Active hepatitis B, hepatitis C, or HIV infection
- Oxygen saturation less than 90% on room air
- Bilirubin levels more than three times the upper normal limit
- Glomerular filtration rate less than 30 ml/min
- Cardiac dysfunction
- Use of corticosteroids at doses that cannot be stopped
- Known allergy to any component of the investigational medicinal product
- Contraindications to lymphodepletion or use of cyclophosphamide or fludarabine per local guidelines
- Pregnant or breastfeeding women
- Life expectancy less than 3 months
- Fulminant or rapidly progressive disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
University College London Hospitals
London, United Kingdom
Actively Recruiting
Research Team
F
FRACTALL Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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