Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04214886
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-08-15
First Post:
2019-12-16
Brief Title:
CD19 Chimeric Antigen Receptor CAR T Cells for Adults With Recurrent or Refractory B Cell Malignancies
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
Dose Escalation Study of CD19 Chimeric Antigen Receptor CAR T Cells With a CD34 Selection Marker in Adults With Recurrent or Refractory B Cell Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-08
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:
In this protocol the investigators hypothesize that modifying the process of producing CAR T-cells can help to improve responses and reduce toxicities Building on previous in vitro studies that have shown successful production of CAR T-cells using a new production approach the investigators are now studying the ability to produce these CAR T-cells and determine how well they work in the clinical setting
Detailed Description:
Autologous peripheral blood mononuclear cell PBMC will be obtained by leukapheresis over one day and the cells will be transduced with an in house designed CAR retroviral vector Participants will receive daily intravenous IV infusion of lymphodepleting regimen of fludarabine and cyclophosphamide for total of 3 days Days -5 -4 -3 The dose of cyclophosphamide will be given at 500mgm2 The dose of fludarabine will be given at 30mgm2 Participants will receive the CAR transduced T cells IV infusion in the BMT Inpatient Unit and remain admitted for close monitoring for at least the first 7 days following the cell infusion D0 to Day 7 possibly longer if any side effects are encountered The CAR transduced T cells will be escalated from 1 x 106 transduced T cellskg 20 to 2 x 106 transduced T cellskg 20 in a Phase I design based on toxicity Once discharged from the inpatient unit for the next 7 days Day 8 to Day 14 the patients will be evaluated in the High Dose Unit labs and physical exam to screen for toxicities
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