Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593145
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
CAR T Cells in the Treatment of Refractory and Relapsed CD19 B Cell Neoplasms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application of the Autologous CAR T Cells Tarcidomgen Kimleucel in the Treatment of Refractory and Relapsed CD19 B Cell Neoplasms
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARLA
Brief Summary:
One arm open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 scientific name Tarcidomgen Kimleucel containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 B cell neoplasms
Detailed Description:
The aim of the study is to determine the safety of therapy with the study medicinal product FCTX-CL19-1 Tarcidomgen Kimleucel with preliminary determination of efficacy as part of a phase I clinical trial in patients with relapsed and refractory B-cell CD19 tumors
The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 Tarcidomgen Kimleucel containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment
The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 Tarcidomgen Kimleucel containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment
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