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Clinical Trials in the USA / NCT05822427
Recruiting Observational

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

NCT05822427 · tracked via the Priya Life Science USA tracker
Sponsor
Imugene Limited
Phase
Observational
Started
2020-08-25
Last updated
2025-05-14

Condition(s) studied

Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * No unique exclusion criteria apply to this study.

Primary outcome measure(s)

  • Frequency of Clinically Significant Clinical Events of Interest (CEI) — Up to 15 years
  • Severity of Clinically Significant CEI — Up to 15 years
  • Duration of Clinically Significant CEI — Up to 15 years
  • Outcome of Clinically Significant CEI — Up to 15 years

Trial sites (1)

FacilityCityRegionStatus
Science 37, Inc. Culver City California Recruiting

More Imugene Limited trials in the USA

Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05822427 on ClinicalTrials.gov ↗ ← All trials in the USA