Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464991
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-30
Brief Title:
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM FUMANBA-03
Sponsor:
Nanjing IASO Biotechnology Co Ltd
Organization:
Nanjing IASO Biotechnology Co Ltd
Study Overview
Official Title:
A Phase III Randomized Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory RR Multiple Myeloma
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:
FUMANBA-03
Brief Summary:
This is a multicenter randomized controlled open-label phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy
Detailed Description:
Multiple myeloma MM is a malignant neoplasm of plasma cells that accounts for more than 10-20 of hematologic malignancies worldwide leading to marrow failure and bone destruction Equecabtagene Autoleucel eque-cel is an autologous chimeric antigen receptor T-cell CAR-T therapy that targets B-cell maturation antigen BCMA which expressed on both mature B lymphocytes and malignant plasma cells The primary objective for this study is to compare the efficacy of eque-cel versus standard therapy in lenalidomid-refractory RRMM Subjects will undergo screening with informed consent After enrollment randomization will be conducted followed by study treatment in experimental or control group A follow-up phase will include assessments for safety efficacy evaluation and pharmacokinetics monitoring experimental arm The duration of this trial is about 6 years
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