Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05377827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-12
First Post:
2022-05-11
Brief Title:
Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells WU-CART-007 in Patients With CD7 Hematologic Malignancies
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells WU-CART-007 in Patients With CD7 Hematologic Malignancies
Status:
ACTIVE_NOT_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:
Effective treatment options for relapsedrefractory acute myeloid leukemia AML and T-cell non-Hodgkin lymphoma T-NHL represent a significant unmet medical need CAR T therapy has offered durable remissions and potential cures in some forms of hematologic malignancy including B-cell acute lymphoblastic leukemia In AML however CAR T approaches have been limited by the lack of suitable antigens as most myeloid markers are shared with normal hematopoietic stem cells and targeting of these antigens by CAR T therapy leads to undesirable hematologic toxicity Similarly T-NHL has not yet benefited from CAR T therapy due to a lack of suitable markers One potential therapeutic target is CD7 which is expressed normally on mature T-cells and NK-cells but is also aberrantly expressed on 30 of acute myeloid leukemias CAR T therapy for patients with CD7 AML and T-NHL will potentially offer a new therapeutic option which has a chance of offering durable benefit
WU-CART-007 is a CD7-directed genetically modified allogeneic fratricide-resistant chimeric antigen receptor CAR T-cell product for the treatment of CD7 hematologic malignancies These cells have two key changes from conventional autologous CAR T-cells First because CD7 is present on normal T-cells including conventional CAR T products CD7 is deleted from WU CART-007 This allows for targeting of CD7 without the risk of fratricide killing of WU-CART-007 cells by other WU-CART-007 cells Second the T cell receptor alpha constant TRAC is also deleted This makes WU CART 007 cells incapable of recognizing antigens other than CD7 and allows for the use of an allogeneic product without causing Graft-versus-Host-Disease GvHD
WU-CART-007 is a CD7-directed genetically modified allogeneic fratricide-resistant chimeric antigen receptor CAR T-cell product for the treatment of CD7 hematologic malignancies These cells have two key changes from conventional autologous CAR T-cells First because CD7 is present on normal T-cells including conventional CAR T products CD7 is deleted from WU CART-007 This allows for targeting of CD7 without the risk of fratricide killing of WU-CART-007 cells by other WU-CART-007 cells Second the T cell receptor alpha constant TRAC is also deleted This makes WU CART 007 cells incapable of recognizing antigens other than CD7 and allows for the use of an allogeneic product without causing Graft-versus-Host-Disease GvHD
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?:
False
Is an FDA AA801 Violation?:
None