Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-01 @ 7:11 PM
Study NCT ID:
NCT07085559
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
Sponsor:
Anhui Provincial Hospital
Organization:
Study Overview
Official Title:
Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
Status:
RECRUITING
Status Verified Date:
2025-07
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 BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.
Detailed Description:
This is an open-label study. This study is indicated for relapsed or refractory Plasma Cell Neoplasms.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.
1. Main research objectives:
To evaluate the safety and tolerability of metabolically armed BCMA CAR-T Cells in the treatment of r/r plasma cell neoplasms.
2. Secondary research objectives:
(1)To evaluate the pharmacokinetic (PK) and pharmacodynamics (PD) characteristics of metabolically armed BCMA CAR-T cells after infusion.
(2) To evaluate tumor remission after infusion of metabolically armed BCMA CAR-T Cells.
1. Main research objectives:
To evaluate the safety and tolerability of metabolically armed BCMA CAR-T Cells in the treatment of r/r plasma cell neoplasms.
2. Secondary research objectives:
(1)To evaluate the pharmacokinetic (PK) and pharmacodynamics (PD) characteristics of metabolically armed BCMA CAR-T cells after infusion.
(2) To evaluate tumor remission after infusion of metabolically armed BCMA 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?:
None
Is an FDA AA801 Violation?: