Phase I study of base edited CAR7 T cells to treat T cell malignancies (TvT CAR7)

Great Ormond Street Hospital0 个研究点目标入组 10 人开始时间: 2022年4月6日最近更新: 2024年4月29日

适应症

试验速览

2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37314354/ (added 15/06/2023)

•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

•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

发起方

Great Ormond Street Hospital