Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified

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 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

, , 

Location Countries

Netherlands

Location Countries

Netherlands

NCT ID

NCT03628612

Organization ID

AUTO-LT1

Responsible Party

Sponsor

Study Sponsor

Autolus Limited

Study Sponsor

, , 

Verification Date

August 2020