Back to resultsLong-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified
Primary Purpose
Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL
Status
Enrolling by invitation
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AUTO CAR T cell therapy
Sponsored by
About this trial
This is an interventional other trial for Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
Eligibility 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.
Sites / Locations
- University College London Hospitals NHS Foundation Trust
- Manchester Royal Infirmary Hospital
- Royal Manchester Children's Hospital
- Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AUTO CAR T cell therapy
Arm Description
Patients who received previous treatment with AUTO CAR T Cell Therapy
Outcomes
Primary Outcome Measures
Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy
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.
Overall Survival following first AUTO CAR T cell therapy infusion.
B-Cell / T-cell aplasia
Duration of supportive care
Duration of response
Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.
Progression-free survival
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
Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628612
Brief Title
Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified
Official Title
Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
July 2043 (Anticipated)
Study Completion Date
December 2043 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autolus Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL, ALL, Adult and Pediatric, T Cell Lymphoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AUTO CAR T cell therapy
Arm Type
Experimental
Arm Description
Patients who received previous treatment with AUTO CAR T Cell Therapy
Intervention Type
Biological
Intervention Name(s)
AUTO CAR T cell therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy
Description
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.
Time Frame
For up to 15 years
Secondary Outcome Measure Information:
Title
Overall Survival following first AUTO CAR T cell therapy infusion.
Description
Overall Survival following first AUTO CAR T cell therapy infusion.
Time Frame
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
Title
B-Cell / T-cell aplasia
Description
Duration of supportive care
Time Frame
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
Title
Duration of response
Description
Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.
Time Frame
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
Title
Progression-free survival
Description
Progression free survival following first AUTO CAR T cell therapy infusion.
Time Frame
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
Title
Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion
Description
Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion
Time Frame
For up to 15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary Hospital
City
Manchester
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
Country
United Kingdom
Facility Name
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified
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