Potential malignancy in patients who received treatment with Autolus CAR T cell therapy.
Conditions
Brief summary
Incidence of serious adverse events related to AUTO CAR T cell therapy, New malignancies, Other designated adverse events of special interest related to AUTO CAR T cell therapy
Detailed description
Overall survival for up to 15 years after the first AUTO CAR T cell therapy infusion, Duration of supportive care, Duration of response, progression-free survival, Proportion of patients with detectable vector copy number in peripheral blood for up to 15 years from first AUTO CAR T cell therapy infusion, Confirm / monitor for absence of detectable RCR/RCL for up to 15 years from first AUTO CAR T cell therapy infusion, In case of new malignancy: Insertion site analysis to determine insertional mutagenesis as potential cause/contributor
Sponsors
Autolus Limited
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events related to AUTO CAR T cell therapy, New malignancies, Other designated adverse events of special interest related to AUTO CAR T cell therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival for up to 15 years after the first AUTO CAR T cell therapy infusion, Duration of supportive care, Duration of response, progression-free survival, Proportion of patients with detectable vector copy number in peripheral blood for up to 15 years from first AUTO CAR T cell therapy infusion, Confirm / monitor for absence of detectable RCR/RCL for up to 15 years from first AUTO CAR T cell therapy infusion, In case of new malignancy: Insertion site analysis to determine insertional mutagenesis as potential cause/contributor | — |
Countries
Spain
Outcome results
None listed