Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2020-12-26
Brief Title:
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma
Sponsor:
Zou Dehui
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
The primary objective of this study is to explore the safety and efficacy of CNCT19 a second-generation anti-CD19 CAR T-cell using 4-1BB as co-stimulatory domain provided by Juventas Tianjin China infusion following ASCT in patients with relapsed or refractory B-cell lymphoma
Detailed Description:
This is a single-center non-randomized open-label prospective clinical trial to evaluate the safety and efficacy of CNCT19 infusion following high-dose chemotherapy and autologous stem-cell transplantation HDTASCT in patients with relapsed or refractory B-cell lymphoma CNCT19 cells will be infused on day 3 1d with a fixed dose of 2106kg The study will assess the safety and efficacy of this combinational therapy including the incidence and severity of cytokine release syndrome CRS immune effector cell-associated neurotoxicity syndrome ICANS hematological and other non-hematological toxicities and objective response rates and complete response rates and survivals of the subjects
Study Oversight
Has Oversight DMC:
None
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?:
None