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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy
Secondary Outcome
Overall Survival following first AUTO CAR T cell therapy infusion.
Condition
Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
Intervention
AUTO CAR T cell therapy
Study Arms / Comparison Groups
AUTO CAR T cell therapy
Description: Patients who received previous treatment with AUTO CAR T Cell Therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
500
Start Date
August 3, 2018
Completion Date
December 2032
Primary Completion Date
July 2032
Eligibility Criteria
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 exclusion criteria for this study.
Gender
All
Ages
1 Year - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03628612
Organization ID
AUTO-LT1
Responsible Party
Sponsor
Study Sponsor
Autolus Limited
Study Sponsor
, ,
Verification Date
February 2022