Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05350163
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2022-04-22
Brief Title:
T-cell Receptor αβ Depleted Donor Lymphocyte Infusion
Sponsor:
Baptist Health South Florida
Organization:
Baptist Health South Florida
Study Overview
Official Title:
Phase I Dose Escalation of T-cell Receptor αβ Depleted Donor Lymphocyte Infusions Following CD34- Selected Allogeneic Stem Cell Transplantation From Related Unrelated Donors in Patients With Lymphoid Myeloid or Plasma Cell Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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 pilot study is being conducted to treat patients who have a certain type of malignancy lymphoid or myeloid with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation TCD HSCT
This study is designed to see whether an investigational cellular product of immune cells obtained from a donors cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status infectious complication progression-free and overall survival
This study is designed to see whether an investigational cellular product of immune cells obtained from a donors cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status infectious complication progression-free and overall survival
Detailed Description:
None
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