Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365671
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
CAR-T Following ASCT for RelapsedRefractory B-Cell Non-Hodgkins Lymphoma RR B-NHL With High-Risk Prognostic Factors
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for RelapsedRefractory B-Cell Non-Hodgkins Lymphoma RR B-NHL With High-Risk Prognostic Factors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation ASCT for RelapsedRefractory B-Cell Non-Hodgkins Lymphoma RR B-NHL with High-Risk Prognostic Factors
Detailed Description:
This is a single-center single-arm open-label prospective clinical trial to evaluate the efficacy and safety of Relmacabtagene autoleucel relma-cel infusion following high-dose chemotherapy and autologous stem-cell transplantation HDTASCT in relapsed or refractory B-cell Non-Hodgkins Lymphoma patients with high-risk prognostic factors extranodal involvementbulky mass 5 cm in diameterTP53 alterations Relma-cel will be infused on day 3 1d with a fixed dose of 100X106 The study will assess the safety and efficacy of this combinational therapy including the investigators assessed the best complete response rate BCR in 3 months primary endpoint objective response rates survivals incidence and severity of cytokine release syndrome CRS immune effector cell-associated neurotoxicity syndrome ICANS hematological and other non-hematological toxicities 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