Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Patients may be enrolled following their AUTO CAR T cell therapy treatment and will be followed for up to 15 years (or death, whichever happens first) after the first AUTO CAR T cell therapy infusion. Patients will be monitored for safety following the first AUTO CAR T cell therapy infusion.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AUTO CAR T cell therapy Patients who received previous treatment with AUTO CAR T Cell Therapy |
Biological: AUTO 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy [For up to 15 years]
Monitoring of all serious adverse events/ adverse events of special interest, 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 Outcome Measures
- 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.
- B-Cell / T-cell aplasia [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]
Duration of supportive care
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
-
Patients must have provided informed consent for long-term follow-up study prior to participation.
-
Patients must be able to comply with the study requirements.
Exclusion Criteria:
- There are no specific exclusion criteria for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University College London Hospitals NHS Foundation Trust | London | United Kingdom | ||
| 2 | Manchester Royal Infirmary Hospital | Manchester | United Kingdom | ||
| 3 | Royal Manchester Children's Hospital | Manchester | United Kingdom | ||
| 4 | Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | United Kingdom |
Sponsors and Collaborators
- Autolus Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AUTO-LT1