Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT03093168
Status:
UNKNOWN
Last Update Posted:
2019-02-27
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
Sponsor:
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Organization:
Study Overview
Official Title:
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2018-03
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:
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
Detailed Description:
Primary Objectives
1. To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
2. To determine in vivo dynamics and persistency of BCMA CAR-T cells.
3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.
Secondary Objectives
1. To assess the bone marrow and tumor migration of BCMA CAR-T cells.
2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro
3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
1. To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
2. To determine in vivo dynamics and persistency of BCMA CAR-T cells.
3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.
Secondary Objectives
1. To assess the bone marrow and tumor migration of BCMA CAR-T cells.
2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro
3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
Study Oversight
Has Oversight DMC:
True
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?: