Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImugene Limited

About this trial

The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:

* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)? * What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?

Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Receipt of at least 1 dose of azer-cel in an Imugene clinical study.

A signed informed consent form (ICF).

Willingness and ability to adhere to the study schedule and all other protocol requirements.

Disqualifiers

No unique exclusion criteria apply to this study.

Trial population

Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Frequency of Clinically Significant Clinical Events of Interest (CEI)

Time frame
Up to 15 years
2

Severity of Clinically Significant CEI

Time frame
Up to 15 years
3

Duration of Clinically Significant CEI

Time frame
Up to 15 years
4

Outcome of Clinically Significant CEI

Time frame
Up to 15 years

Secondary outcomes

1

Duration of Disease Response

Time frame
Up to 15 years
2

Overall Survival Rate

Time frame
Up to 15 years
3

Azer-cel Persistence

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

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