Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNanjing IASO Biotechnology Co., Ltd.

About this trial

This is a multicenter, open-label, single-arm, long-term follow-up clinical study. All patients who have received Equecabtagene Autoleucel Injection treatment will be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1. Receipt of another lentiviral vector-based cell or gene therapy (either commercialized product or investigational product in a clinical tiral) between the infution of Equecabtagene Autoleucel Injection and the signing informed consent.

Trial population

All patients who have received Equecabtagene Autoleucel Injection treatment. Patients who participated in pre-marketing clinical studies or post-marketing real-world studies with this product can only be enrolled after completing or prematurely withdrawing from their original studies.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )

    Other intervention

    This study is observational study and all participants will be obsreved with no intervention.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: All patients received Equecabtagene Autoleucel Injection1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.

Time frame
Up to 15 years from enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

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