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

Autolus

Status and phase: Invitation-only; Phase 2

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

Treatments: Biological: AUTO CAR T cell therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628612

AUTO-LT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

AUTO CAR T cell therapy

Experimental group

Description:

Patients who received previous treatment with AUTO CAR T Cell Therapy

Treatment:

Biological: AUTO CAR T cell therapy