Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393335
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-28
Brief Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells Meta10-19 in the Treatment of Relapsed andor Refractory CD19-positive B Cell Hematological Malignancies Clinical Research
Sponsor:
The Childrens Hospital of Zhejiang University School of Medicine
Organization:
The Childrens Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells Meta10-19 in the Treatment of Relapsed andor Refractory CD19-positive B Cell Hematological Malignancies Clinical Research
Status:
RECRUITING
Status Verified Date:
2024-04
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 andor Refractory CD19-positive B cell Hematological Malignancies
Detailed Description:
This is a single arm open-label study This study is indicated for relapsed or refractory CD19-positive B cell Hematological Malignancies
1 Main research objectives
To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of rr CD19-positive B cell Hematological Malignancies
2 Secondary research objectives
1 To evaluate the pharmacokinetic PK and pharmacodynamicsPD 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 rr CD19-positive B cell Hematological Malignancies
2 Secondary research objectives
1 To evaluate the pharmacokinetic PK and pharmacodynamicsPD 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:
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