Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02500550
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2015-07-14
Brief Title:
Safety and Efficacy of Two Doses of ATIR101 a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Sponsor:
Kiadis Pharma
Organization:
Kiadis Pharma
Study Overview
Official Title:
An Exploratory Open-label Multicenter Study to Evaluate the Safety and Efficacy of a Two-dose Regimen of ATIR101 a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells Using Photodynamic Treatment in Patients With a Hematologic Malignancy Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Status:
COMPLETED
Status Verified Date:
2021-05
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:
The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor All patients are planned to receive two ATIR101 doses of 210E6 viable T-cellskg unless the second dose is reduced or halted for safety reasons
Detailed Description:
Study CR-AIR-008 is an exploratory open-label multicenter study After signing informed consent patients will receive a hematopoietic stem cell transplantation HSCT from a related haploidentical donor followed by a first ATIR101 infusion at a dose of 210E6 viable T-cellskg between 28 and 32 days after the HSCT Patients will receive a second ATIR101 infusion at a dose of 210E6 viable T-cellskg between 70 and 74 days after the HSCT To evaluate safety of the second dose administration the first 6 patients treated will be evaluated for the occurrence of dose limiting toxicity DLT defined as acute GvHD grade IIIIV within 120 days post HSCT or within 42 days after the second ATIR101 infusion in case of prior dose delays If within the first 6 patients no DLT is observed treatment of the remaining 9 patients will continue with two ATIR101 doses of 210E6 viable T cellskg If within the first 6 patients at least 2 patients show DLT the second ATIR101 infusion will be adjusted to a dose of 110E6 viable T cellskg If in one of the next 3 patients treated at this lower dose again DLT is observed the second ATIR101 infusion will be halted and the remaining patients will be given only a single dose of ATIR101
All patients treated with ATIR101 will be followed up until 12 months after the HSCT Assessments will be performed at weekly visits from the day of the first ATIR101 infusion Week 4 until 6 weeks after the second ATIR101 infusion Week 16 at monthly visits from 4 until 6 months after the HSCT and every 3 months from 6 until 12 months after the HSCT
All patients treated with ATIR101 will be followed up until 12 months after the HSCT Assessments will be performed at weekly visits from the day of the first ATIR101 infusion Week 4 until 6 weeks after the second ATIR101 infusion Week 16 at monthly visits from 4 until 6 months after the HSCT and every 3 months from 6 until 12 months after the HSCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None