Long-term follow-up for patients who received CAR T-cell therapy
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
This study is checking how people who had CAR T-cell therapy feel and do over the long term, by following them for up to 15 years to see if there are any lasting effects or health changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imugene Limited Industry-sponsored |
| Drugs / interventions | CAR T, Chimeric Antigen Receptor |
| Locations | 1 site (Culver City, California) |
| Trial ID | NCT05822427 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather long-term safety data on participants who received an allogeneic chimeric antigen receptor (CAR) T-cell product, specifically azer-cel, in a previous clinical study by Imugene. Participants will attend yearly visits for up to 15 years to monitor clinically significant events, response duration, and overall survival. The study does not involve administering azer-cel but allows for standard care or other investigational treatments. The focus is on understanding the long-term effects and outcomes of the CAR T-cell therapy.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously received at least one dose of azer-cel in an Imugene clinical study.
Not a fit: Patients who have not received azer-cel or those who do not wish to participate in long-term follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of CAR T-cell therapies, improving patient management and treatment strategies.
How similar studies have performed: While long-term follow-up studies for CAR T-cell therapies are common, this specific observational approach focusing on azer-cel is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Culver City, California
- Science 37, Inc. — Culver City, California, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Imugene Limited
- Email: info@imugene.com
- Phone: 1 984 245 0082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.