Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 2:59 PM
Study NCT ID:
NCT06120166
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2023-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Sponsor:
He Huang
Organization:
Study Overview
Official Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r/r DLBCL Clinical Research
Status:
RECRUITING
Status Verified Date:
2025-09
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:
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma
Detailed Description:
This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19+ Diffuse Large B-Cell Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products.
1. Main research objectives:
To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r DLBCL.
2. Secondary research objectives:
1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.
2. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.
1. Main research objectives:
To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r DLBCL.
2. Secondary research objectives:
1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.
2. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: