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

Phase 2Enrolling By InvitationNCT03628612

Autolus Limited500 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

500

Conditions

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

Interventions

AUTO CAR T cell therapyBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Locations (8)

University of Miami

Miami, Florida, United States

Washington University in St. Louis

St Louis, Missouri, United States

St David's South Austin Medical Center

Austin, Texas, United States

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: For up to 15 years

Secondary Outcomes

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

Duration of supportive care

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

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

Duration of response

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

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

Progression free 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

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

Data from ClinicalTrials.gov

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