KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed/refractory (r/r) B cell malignancies.
Age 16-65 years
CD19+ disease
Agreement to have a pregnancy test, use adequate contraception (if applicable)
Written informed consent
CD19 negative disease
Active CNS involvement of disease
Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
Active hepatitis B, C or HIV infection
Single group
KCAT19 T cells
GeneticAllogeneic, cord unit derived KCAT19 T cells
KCAT 19 T cell generation feasibility
Feasibility of generation of T cell receptor-negative KCAT19 T cells as evaluated by the number of therapeutic products generated.
KCAT19 T cell Toxicity
Toxicity following KCAT19 T cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Response rate
Proportion of responders and depth of response at 1 and 6 months post ATIMP infusion
KCAT19 T cell persistence
Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by flow cytometry
KCAT19 T cell persistence
Persistence and frequency of circulating KCAT19 T cells in peripheral blood as assessed by qPCR
Hypogammaglobulinaemia and B cell aplasia
Incidence and duration of hypogammaglobulinaemia and B cell aplasia
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