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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Relapsed/refractory T-cell acute lymphoid leukaemia
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T-cell leukaemia is an uncommon type of blood cell cancer that affects white blood cells (T cells). This phase I clinical trial will treat patients aged 6 months and above with T cell leukaemia which has come back (relapsed) after chemotherapy or is not responding to chemotherapy (refractory). The cell therapy is made from white blood cells (T cells) collected from a healthy donor and changed so they can kill other T cells, including leukaemia cells. These ‘ready-made’ CAR T cells have been made using a new technique called CRISPR base editing to modify their DNA code and have been given the name BE CAR-7. This technique allows them to work after chemotherapy and also disarms them to prevent effects against normal cells. The main aim of this study is to assess the safety of the BE CAR-7 treatment and to see if ready-made CAR T cells can eradicate T cell leukaemia ahead of a planned bone marrow transplant.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2025 Results article in https://pubmed.ncbi.nlm.nih.gov/41363805/ (added 30/12/2025)2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37314354/ (added 15/06/2023)
You can take part if:
Current inclusion criteria as of 23/05/2025:
Demographic characteristics:
1. Male or female patients
2. Aged 6 months and above
Medical and therapeutic criteria:
1. Relapsed/refractory T cell malignancy ahead of planned allogeneic haematopoietic stem cell transplantation (allo-SCT). Morphologically confirmed with leukemic blasts in the bone marrow (>5%) or a quantifiable MRD load (by multiparameter flow cytometry and/or quantitative polymerase chain reaction)
2. CD7+ (>99%) leukaemia-associated immunophenotype (LAIP)
3. Eligible and fit for allogeneic hematopoietic stem cells transplantation with suitable donor available
4. Estimated life expectancy ≥12 weeks
5. Lansky (age <16 years at the time of assent/consent) or Karnofsky (age ≥16 years at the time of assent/consent) performance status ≥70; Eastern Cooperative Oncology Grou
You may not be able to take part if:
1. Patients/parents unwilling to undergo a follow-up for 15 years2. Foreseeable poor compliance to the study procedures3. Evidence of disease progression after cytoreduction4. Uncontrollable CNS leukaemia or neurological symptoms defined as CNS grade 3 (per National Comprehensive Cancer Network guidelines)5. Absence of suitable HLA matched or mismatched donor6. Weight <6 kg7. Presence of donor-specific anti-HLA antibodies directed against BE-CAR78. GvHD requiring systemic therapy9. Systemic steroid therapy prednisolone >0.5 mg/kg/day10. Known hypersensitivity to any of the test materials or related compounds11. Active bacterial, fungal or viral infection not controlled by standard of care anti-microbial or anti-viral treatment. Uncontrolled bacteraemia/ fungaemia is defined as the ongoing detection of bacteria/fungus on blood cultures despite antibiotic or antifungal therapy. Uncontrolled viraemia is defined as rising viral loads on two consecutive occasions despite antiviral therapy.12. Risk of pregnancy or non-compliance with contraception (if applicable). Girls of childbearing potential must have been tested negative in a pregnancy test within 14 days prior to inclusion.13. Lactating female participants unwilling to stop breastfeeding14. Prior CAR therapy known to be associated with ≥Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug-related CNS toxicity
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Great Ormond Street Hospital and funded by Medical Research Council.
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