Anti-CCR9 CAR T-cell therapy for T‑cell acute lymphoblastic leukaemia and lymphoblastic lymphoma
Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma
We will try anti-CCR9 CAR T cells made from your own blood to find a dose that is safe for children and adults with relapsed or refractory T‑cell leukaemia or lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | cyclophosphamide, fludarabine, CAR T, CAR-T, chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT07300683 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial uses autologous CAR T cells engineered to target CCR9 and modified to resist fratricide. After blood collection, patients receive a short course of lymphodepleting chemotherapy and a single intravenous CAR T-cell infusion, followed by at least two weeks of inpatient monitoring. The study follows a dose-escalation format to identify safety, tolerability, and a recommended dose while monitoring for expected side effects such as cytokine release syndrome and neurologic events. Participants return for approximately a dozen clinic visits over two years with blood tests, bone marrow biopsies and imaging as needed.
Who should consider this trial
Good fit: Ideal candidates are children and adults with relapsed or refractory CCR9‑positive T‑ALL or T‑LBL who have received the required prior lines of chemotherapy and meet organ function and performance-status criteria.
Not a fit: Patients with CCR9‑negative disease, active uncontrolled infections (including hepatitis B, C or HIV), active CNS involvement, significant organ dysfunction, uncontrolled graft‑versus‑host disease, or who require high-dose steroids are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this therapy could produce remissions in some patients with relapsed or refractory CCR9‑positive T‑cell leukaemia or lymphoma who have limited treatment options.
How similar studies have performed: CAR T-cell therapy has been highly effective for B‑cell cancers, but CAR T approaches for T‑cell malignancies are relatively novel and technically challenging, making the anti‑CCR9 approach an early-stage strategy with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
London
- University College London Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: FRACTALL Trial Manager
- Email: ctc.fractall@ucl.ac.uk
- Phone: +44 (0)20 76705748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.