Status:
UNKNOWN
Base Edited CAR7 T Cells to Treat T Cell Malignancies (TvT CAR7)
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsors:
UCL Great Ormond Street Institute of Child Health
Medical Research Council
Conditions:
Relapsed/Refractory T-cell Acute Lymphoid Leukaemia
Eligibility:
All Genders
6-16 years
Phase:
PHASE1
Brief Summary
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 w...
Detailed Description
Who can participate? Patients aged 6 months to 16 years with relapsed/refractory T cell leukaemia ahead of a planned bone marrow transplant What does the study involve? Patients will undergo careful ...
Eligibility Criteria
Inclusion
- Demographic characteristics:
- Male or female patients
- Age ranging between 6 months and \<16 years
- Medical and therapeutic criteria:
- 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)
- CD7+ (\>99%) leukaemia associated immunophenotype (LAIP)
- Eligible and fit for allogeneic hematopoietic stem cells transplantation with suitable donor available
- Estimated life expectancy ≥12 weeks
- 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:
- Patients/parents unwilling to undergo a follow-up for 15 years
- Foreseeable poor compliance to the study procedures
- Evidence of disease progression after cytoreduction
- Uncontrollable CNS leukaemia or neurological symptoms defined as CNS grade 3 (per National Comprehensive Cancer Network guidelines)
- Absence of suitable HLA matched or mismatched donor
- Weight \<6 kg
- Presence of donor-specific anti-HLA antibodies directed against BE-CAR7
- GvHD requiring systemic therapy
- Systemic steroid therapy prednisolone \>0.5 mg/kg/day
- Known hypersensitivity to any of the test materials or related compounds
- 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.
- 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.
- Lactating female participants unwilling to stop breastfeeding
- Prior CAR therapy known to be associated with ≥Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug-related CNS toxicity
Exclusion
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05397184
Start Date
April 19 2022
End Date
February 28 2025
Last Update
July 5 2023
Active Locations (1)
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1
Ilyas Ali
London, United Kingdom, WC1N 1EH