Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT03767751
Status:
UNKNOWN
Last Update Posted:
2018-12-07
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA
Status:
UNKNOWN
Status Verified Date:
2018-12
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:
CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.
Detailed Description:
1. PRIMARY OBJECTIVES:
1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.
2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.
2. SECONDARY OBJECTIVES:
1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.
2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.
1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.
2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.
2. SECONDARY OBJECTIVES:
1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.
2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.
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?: