Refractory Systemic Autoimmune Diseases
Conditions
Brief summary
- Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell Associated Neurotoxicity Syndrome (ICANS) within the first 4 weeks after ATMP administration. - Incidence and severity of infections and leukopenia and/or hypogammaglobulinemia during the entire study period.
Detailed description
a) Duration of B cell depletion in the peripheral blood: CD19+ B cells assessed by fluorescence- activated cell sorting (FACS) equal to 0 up to week 24 and long-term FU. b) Duration of persistence of CAR T cells in the peripheral blood: CAR+ CD3+ cells assessed by FACS > 0 up to week 24 and long-term FU. c) Changes in the levels of disease-associated serum autoantibodies at week 24 including incidence of seroconversion (anti-dsDNA < LLN; ANA <1.100; all others “negative”) o SLE
Interventions
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell Associated Neurotoxicity Syndrome (ICANS) within the first 4 weeks after ATMP administration. - Incidence and severity of infections and leukopenia and/or hypogammaglobulinemia during the entire study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Duration of B cell depletion in the peripheral blood: CD19+ B cells assessed by fluorescence- activated cell sorting (FACS) equal to 0 up to week 24 and long-term FU. b) Duration of persistence of CAR T cells in the peripheral blood: CAR+ CD3+ cells assessed by FACS > 0 up to week 24 and long-term FU. c) Changes in the levels of disease-associated serum autoantibodies at week 24 including incidence of seroconversion (anti-dsDNA < LLN; ANA <1.100; all others “negative”) o SLE | — |
Countries
Italy
Outcome results
None listed