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Enrolling by Invitation

NCT Number: NCT03628612

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

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.

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Key information

Conditions

Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy ALL, Adult and Pediatric Blood Protein Disorders Cardiovascular Diseases DLBCL Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias T Cell Lymphoma Vascular Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Elizabeth University Hospital, Glasgow, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AUTO CAR T cell therapy

Biological

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 outcomes

  1. Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy

    Time frame: For up to 15 years

    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.

Secondary outcomes

  1. 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

    Overall Survival following first AUTO CAR T cell therapy infusion.

  2. 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

    B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy.

  3. Duration of response

    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

    Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.

  4. Progression-free survival

    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

    Progression free survival following first AUTO CAR T cell therapy infusion.

  5. Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion

    Time frame: For up to 15 years

    Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion

  6. Proportion of patients with detectable vector copy number (VCN) in peripheral blood

    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

    Blood sample collection for VCN measurement to detect persistence of CAR transgene(s)

  7. Testing for Insertional mutagenesis in case of a new malignancy

    Time frame: For up to 15 years

    Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy.

Sponsors and collaborators

Lead sponsor

Autolus Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2043
Study completion
2043
First posted
Aug 14, 2018
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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