ALL, Adult and Pediatric, DLBCL, Multiple Myeloma, Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, T Cell Lymphoma
Conditions
Brief summary
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Detailed description
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
Interventions
BIOLOGICALAUTO CAR T cell therapy
No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
Sponsors
Autolus Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. 2. Patients must have provided informed consent for long-term follow-up study prior to participation. 3. Patients must be able to comply with the study requirements.
Exclusion criteria
1. There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy | For up to 15 years | Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of supportive care | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 | B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy. |
| Duration of response | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 | Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression. |
| Progression-free survival | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 | Progression free survival following first AUTO CAR T cell therapy infusion. |
| Overall Survival following first AUTO CAR T cell therapy infusion. | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 | Overall Survival following first AUTO CAR T cell therapy infusion. |
| Proportion of patients with detectable vector copy number (VCN) in peripheral blood | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 | Blood sample collection for VCN measurement to detect persistence of CAR transgene(s) |
| Testing for Insertional mutagenesis in case of a new malignancy | For up to 15 years | Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy. |
| Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion | For up to 15 years | Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion |
Countries
United Kingdom, United States
Outcome results
None listed