Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 2:34 AM
Study NCT ID:
NCT07101705
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of OriV508 injection for patients with relapsed/refractory hematological malignancies.
Detailed Description:
This investigator-initiated clinical study aims to evaluate OriV506 injection, the self-inactivating lentiviral vector that carries a BCMA/CD19 dual-target CAR, in patients with relapsed refractory B-cell hematological malignancies. The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.
Study Oversight
Has Oversight DMC:
None
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?: