Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429150
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-14
Brief Title:
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The aim of this clinical trial is to assess the feasibility safety and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body
Detailed Description:
Multiple myeloma MM is the second most common malignant hematological cancer in the world which begins with the malignant proliferation of plasma cells in bone marrow It has been a difficult disease to treat and most patients will eventually relapse especially for those with high-risk genotypes At present the therapeutic drugs for MM include glucocorticoids cytotoxic drugs immunosuppressants protease inhibitors monoclonal antibodies and cell therapies Among those immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease The frequently targeted MM antigens include CD38 CD138 CD19 and BCMA and recently GPRC5D
BCMA the B cell maturation antigen also known as CD269 or TNFRSF17 is a member of tumor necrosis factor receptor superfamily which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells It has been an ideal target for MM immunotherapy
GPRC5D the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein is highly expressed on the surface of plasma cells but not in other healthy cells and thus it has become a potential target for the treatment of MM The expression of GPRC5D is unrelated to BCMA so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients
This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body
BCMA the B cell maturation antigen also known as CD269 or TNFRSF17 is a member of tumor necrosis factor receptor superfamily which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells It has been an ideal target for MM immunotherapy
GPRC5D the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein is highly expressed on the surface of plasma cells but not in other healthy cells and thus it has become a potential target for the treatment of MM The expression of GPRC5D is unrelated to BCMA so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients
This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body
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