Clinical trial · Interventional
Base Edited CAR7 T Cells to Treat T Cell Malignancies (TvT CAR7)
Phase 1 Study of Base Edited CAR7 T Cells to Treat T Cell Malignancies (TvT CAR7)
- 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)
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 children aged 6 months up to 16 years 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 them 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory T-cell Acute Lymphoid Leukaemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryopreserved BE CAR7 T cells (BE752TBCCLCAR7PBL) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-dose intravenous infusion of a banded dose of CAR7+ T cells/kg BECAR7
- description
- Single-dose intravenous infusion (weight-based dosing) of CAR7+ T cells/kg BECAR7 Total duration of treatment: 28 days Follow-up: 12 months Patients will undergo careful screening to confirm that this treatment is adequate for them. Chemotherapy will be given prior to BE CAR-7 infusion. Patients will then receive a single infusion of the BE CAR-7 cells and will be closely monitored in hospital via blood and bone marrow tests for safety and to check the levels of BE CAR-7 and leukaemia cells. Patients are expected to be in hospital for 4-6 weeks for the BE CAR-7 therapy and the transplant will be scheduled 2-4 weeks after the end of BE CAR7 if leukaemia cells are no longer detectable. Patients will be monitored on the study for 1 year every month for the first 3 months and then every 6 months and then long term in routine clinics.
- interventionNames
- Biological: Cryopreserved BE CAR7 T cells (BE752TBCCLCAR7PBL)
Primary outcomes (1)
- measure
- Frequency and description of adverse events after BE-CAR7 infusion
- timeFrame
- 1 year
- description
- Incidence of Grade 3-5 toxicities occurring from infusion up to one year follow-up. Severe Adverse Reactions of special interest will be CRS, ICANS and GvHD. American Society of Bone Marrow Transplantation grading scales for CRS/ICANS and National Institute of Health criteria for GVHD will be applied. Commo Terminology Criteria nomenclature will be used to grade other adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 16 Years
Show eligibility criteria text
Demographic characteristics: 1. Male or female patients 2. Age ranging between 6 months and \<16 years 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 Group ECOG performance status \< 2 Exclusion Criteria: 1. Patients/parents unwilling to undergo a follow-up for 15 years 2. Foreseeable poor compliance to the study procedures 3. Evidence of disease progression after cytoreduction 4. 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 donor 6. Weight \<6 kg 7. Presence of donor-specific anti-HLA antibodies directed against BE-CAR7 8. GvHD requiring systemic therapy 9. Systemic steroid therapy prednisolone \>0.5 mg/kg/day 10. Known hypersensitivity to any of the test materials or related compounds 11. 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 breastfeeding 14. Prior CAR therapy known to be associated with ≥Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug-related CNS toxicity
References
Publications (0)
Data not yet available