Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-30 @ 3:08 PM
Study NCT ID:
NCT05453669
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell NHL
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
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:
To evaluate the safety and tolerability of CD19-CAR-DNT cells infusion in subjects with relapsed/refractory B-cell non-Hodgkin's Lymphoma
Detailed Description:
This is an open, single-arm, single-dose, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose of CD19-CAR-DNT cells, the safety, the preliminary efficacy and the pharmacokinetic profile of CD19-CAR-DNT cells in vivo after infusion in clinical studies. 9 patients are planned to be enrolled in the dose-escalation trial (1×10\^6 CD19-CAR-DNT cells/kg, 3×10\^6 CD19-CAR-DNT cells/kg, 9×10\^6 CD19-CAR-DNT cells/kg) and 3 patients in the dose-expansion trial. The primary endpoints are DLT, MTD, and the incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.
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?: