Overview
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.
Eligibility
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