Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 10:29 PM
Study NCT ID:
NCT07474051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials
Sponsor:
AvenCell Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSIST
Brief Summary:
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.
Detailed Description:
To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-521717-67-00 | CTIS | None | View |