Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T Cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T Cell Lymphoblastic Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CARCCR9 T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous anti-CCR9 CAR T cells
- description
- Patients will receive autologous anti-CCR9 CAR T cells intravenously.
- interventionNames
- Biological: CARCCR9 T cells
Primary outcomes (2)
- measure
- Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
- timeFrame
- 2 years
- description
- 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.
- measure
- Incidence of treatment-related adverse events (safety and tolerability)
- timeFrame
- From CAR T cells infusion until 28 days post infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available