Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495723
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-18
Brief Title:
Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
Sponsor:
Xenothera SAS
Organization:
Xenothera SAS
Study Overview
Official Title:
Phase III Open-label Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells in Patients with Relapsedrefractory Peripheral T Cells Lymphoma PTCL
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PALT1
Brief Summary:
This is a 2-part study consisting of a Part 1 dose escalation and dose-finding component to establish the Maximal Tolerated Dose MTD or Recommended Part 2 Dose RP2D of LIS1 as a single agent followed by a Part 2 to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma PTCL and to further evaluate its safety and tolerability at RP2D
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509648-88-00 | CTIS | None | None |