B-Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Conditions
Brief summary
Phase I • DLT as per investigator assessment during the first 28 days after CARCIK-CD19 infusion [population: patients treated with CARCIK-CD19] Phase II • Investigator-assessed overall response rate (complete + partial remission) at month 3 after CARCIK-CD19 infusion according to 2014 Lugano criteria (iwCLL 2018 criteria for CLL). [population: patients treated with CARCIK-CD19]
Detailed description
• Incidence of Adverse event (AE) and laboratory abnormalities continuously assessed throughout the study and reported at each scheduled visit. Description and grading of all adverse events will be based on the NCI –CTCAE and MedDRA code (current version) • Persistence and kinetics of CARCIK-CD19 cells in target tissues (blood, bone marrow, and other tissues if available)
Interventions
DRUGPTG-CARCIK-CD19
Sponsors
Fondazione Tettamanti
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I • DLT as per investigator assessment during the first 28 days after CARCIK-CD19 infusion [population: patients treated with CARCIK-CD19] Phase II • Investigator-assessed overall response rate (complete + partial remission) at month 3 after CARCIK-CD19 infusion according to 2014 Lugano criteria (iwCLL 2018 criteria for CLL). [population: patients treated with CARCIK-CD19] | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of Adverse event (AE) and laboratory abnormalities continuously assessed throughout the study and reported at each scheduled visit. Description and grading of all adverse events will be based on the NCI –CTCAE and MedDRA code (current version) • Persistence and kinetics of CARCIK-CD19 cells in target tissues (blood, bone marrow, and other tissues if available) | — |
Countries
Italy
Outcome results
None listed