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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03628612
• Other study ID #: AUTO-LT1
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: August 3, 2018
• Est. completion date: December 2043

Study information

• Verified date: February 2023
• Source: Autolus Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients may be enrolled following their AUTO CAR T cell therapy treatment and will be followed for up to 15 years (or death, whichever happens first) after the first AUTO CAR T cell therapy infusion. Patients will be monitored for safety following the first AUTO CAR T cell therapy infusion.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 2043
• Est. primary completion date: July 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Autolus Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy	Monitoring of all serious adverse events/ adverse events of special interest, 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	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
Secondary	B-Cell / T-cell aplasia	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
Secondary	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
Secondary	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
Secondary	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