Relapsed/refractory T-cell acute lymphoid leukaemia Cancer
Conditions
Interventions
Single-dose intravenous infusion (weight-based dosing) of a banded dose of CAR7+ T cells/kg BE-CAR7
Total duration of treatment: 28 days
Follow-up: 12 months
Patients will undergo careful screening t
Sponsors
Great Ormond Street Hospital
Eligibility
Sex/Gender
All
Age
6 Months to 100 Years
Inclusion criteria
Inclusion criteria: 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 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of BE-CAR7s in patients experiencing relapsed/refractory CD7+ T-ALL; measured at baseline, lymphodepletion, day 0, day 28, and additional points for 12 months post bone marrow transplant (BMT) using: 1. Clinical examination and vital signs 2. Standard blood parameters 3. Oxygen saturation and cardiac assessment 4. Cytokines 5. Infections National Cancer Institute Common Terminology Criteria for Adverse Event will be used to grade events. Specialized grading scales for cytokine release syndrome (CRS) and graft versus host disease (GVHD) will be applied. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease remission ahead of allo-SCT measured by bone marrow examination at day 28 for disease levels by flow and/or molecular MRD. Disease remission is defined as morphological complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) with MRD <10e-3 by flow and/or PCR. | — |
Countries
England, United Kingdom
Outcome results
None listed