Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-13 @ 5:07 PM
Study NCT ID:
NCT05965505
Status:
TERMINATED
Last Update Posted:
2024-08-01
First Post:
2023-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AXT-1003 in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Sponsor:
Axter Therapeutics (Beijing) Co., Ltd
Organization:
Study Overview
Official Title:
An Open-Label, Multicenter, Phase I Study of AXT-1003 as a Single Agent in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the adjustment of the protocol and expansion of the indication population, a new clinical trial protocol was submitted to the Health Authority, so the registration was conducted as a new clinical trial and this trial was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, multicenter, phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in adult subjects with Relapsed/Refractory Non-Hodgkin Lymphomas.
Detailed Description:
The study is being conducted to assess the safety, tolerability, and pharmacokinetics (PK) of AXT-1003 in subjects with relapsed/refractory non-Hodgkin lymphomas (R/R NHL) and relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), a subtype of R/R NHL.
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 |
|---|---|---|---|---|
| CTR20231973 | REGISTRY | http://www.chinadrugtrials.org.cn/index.html | View |