Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393660
Status:
AVAILABLE
Last Update Posted:
2024-06-14
First Post:
2024-04-09
Brief Title:
Treatment Use of the CliniMACS CD34 TCR AlphaBeta for Allogenic Transplant Expanded Access Use
Sponsor:
Victor Aquino
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Treatment Use of the CliniMACS CD34 TCR AlphaBeta to Prepare Cells for an Unlabeled Indication Using an HLA-Compatible Related or Unrelated Donor for Allogenic Transplant
Status:
AVAILABLE
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:
None
Brief Summary:
The protocol is designed to provide access to patients to the Clinimacs CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant
Detailed Description:
Allogeneic hematopoietic stem cell transplant HSCT is the only known curative therapy for a variety of non-malignant and malignant disorders1-4 Only about 25 of patients have an HLA-matched sibling and in about 16-75 depending on ethnicity a 1010 HLA-matched unrelated donor can be identified Engraftment failure is a dynamic complex process that may occur with this product due to unbalanced depletion of T-cells between recipient and donor not only due to low number of CD34 cells The use of mis-matched or haploidentical donors is associated with a higher risk of post-transplant mortality due to the development of severe graft versus host disease graft failure and the development of infection due to the use of immunosuppression or T cell depletion A total of 10 patients will be enrolled The patients will be divided into 2 strata haploidentical 7 unrelated donor 3
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