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

Phase 2

• Conditions: T Cell Lymphoma; ALL, Adult and Pediatric; Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy; DLBCL; Multiple Myeloma

• Registration Number: NCT03628612
• Lead Sponsor: Autolus Limited

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-07-07
• Study Start: 2018-08-02
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2043-07
• Study Completion: 2043-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy	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 Outcome Measures

Name	Time	Method
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	Overall Survival following first AUTO CAR T cell therapy infusion.
Duration of response	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.
Progression-free survival	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.
Duration of supportive care	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.
Testing for Insertional mutagenesis in case of a new malignancy	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.
Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion	For up to 15 years	Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion
Proportion of patients with detectable vector copy number (VCN) in peripheral blood	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)

Trial Locations

Locations (8)

University of Miami; 🇺🇸 Miami, Florida, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

St David's South Austin Medical Center; 🇺🇸 Austin, Texas, United States

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary Hospital; 🇬🇧 Manchester, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom