Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485219
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-22
Brief Title:
A Phase IIa Clinical Study of Puesta Mesylate for Injection in Patients With T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
An Open-Label Multicenter Phase IIa Clinical Study Evaluating the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Puesta Mesylate for Injection for the Treatment of Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Primary Objective To evaluate the preliminary efficacy of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma PTCL and cutaneous T-cell lymphoma CTCL patients Secondary Objectives
1 to evaluate the efficacy of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma PTCL and cutaneous T-cell lymphoma CTCL patients
2 to evaluate the safety and tolerability of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma PTCL and cutaneous T-cell lymphoma CTCL
PTCL and cutaneous T-cell lymphoma CTCL population pharmacokinetic profile
Exploratory Objective
To evaluate the relationship between tumor biomarkers and the therapeutic efficacy and safety of puesta mesylate injection
1 to evaluate the efficacy of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma PTCL and cutaneous T-cell lymphoma CTCL patients
2 to evaluate the safety and tolerability of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma PTCL and cutaneous T-cell lymphoma CTCL
PTCL and cutaneous T-cell lymphoma CTCL population pharmacokinetic profile
Exploratory Objective
To evaluate the relationship between tumor biomarkers and the therapeutic efficacy and safety of puesta mesylate injection
Detailed Description:
None
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?:
None