Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 5:13 AM
Study NCT ID:
NCT03811457
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Sponsor:
UWELL Biopharma
Organization:
Study Overview
Official Title:
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-01
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:
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: