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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Myeloma; DLBCL; T Cell Lymphoma; Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy; ALL, Adult and Pediatric
• Intervention / Treatment: Biological: AUTO CAR T cell therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Queen Elizabeth University Hospital
  • London, United Kingdom
    • University College London Hospitals NHS Foundation Trust
  • Manchester, United Kingdom
    • Royal Manchester Children's Hospital
  • Manchester, United Kingdom
    • Manchester Royal Infirmary Hospital
  • Newcastle Upon Tyne, United Kingdom
    • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Texas
    • Austin, Texas, United States, 78704
      • St David'S South Austin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy	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.	For up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall 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
Duration of response	Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.	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	Progression free 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
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	For up to 15 years
Duration of supportive care	B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy.	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
Proportion of patients with detectable vector copy number (VCN) in peripheral blood	Blood sample collection for VCN measurement to detect persistence of CAR transgene(s)	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
Testing for Insertional mutagenesis in case of a new malignancy	Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy.	For up to 15 years

Collaborators and Investigators

• Sponsor: Autolus Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Estimated): July 1, 2043
• Study Completion (Estimated): December 1, 2043

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma
• Other Study ID Numbers: AUTO-LT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No