Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088654
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-10-12
Brief Title:
Phase12 Study of IPH6501 in Patients With Relapsed Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor:
Innate Pharma
Organization:
Innate Pharma
Study Overview
Official Title:
A Phase 12 Open-Label Multicenter Trial Investigating the Safety Tolerability and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed andor Refractory CD20-expressing Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
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 an international first-in-human multicenter open-label Phase 12 study to evaluate the safety profile tolerability of IPH6501 and determine the recommended phase 2 dose RP2D for patients with B-Cell non-Hodgkin lymphoma
Detailed Description:
In Phase 1 - Dose finding patients with advanced histologically confirmed documented CD20 B-cell non-Hodgkin lymphoma NHL will be enrolled The dose finding part will include 2 sub-parts Dose escalation will determine the Maximum Tolerated Dose MTD or the highest tested dose Dose assessment will determine RP2D
In Phase 2 - Dose expansion one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed documented CD20 B-cell non-Hodgkin lymphoma
In Phase 2 - Dose expansion one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed documented CD20 B-cell non-Hodgkin lymphoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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