Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203912
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-12-12
Brief Title:
Donor Immune Cells TGFbi NK Cells and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma
Sponsor:
Elvira Umyarova
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase Ib Study of TGFbi NK Cells and Isatuximab for Myeloma RelapsedRefractory to BCMA Targeting Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the side effects and best dose of TGFbi natural killer NK cells TiNK when given together with isatuximab for the treatment of patients with multiple myeloma that has come back after a period of improvement relapsed or that has not responded to treatment refractory NK cells are a type of white blood cell that are known to spontaneously attack cancer cells TiNK are NK cells made in a laboratory to have a higher response to tumor cells A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Immunotherapy with monoclonal antibodies such as isatuximab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Patients also receive standard treatment cyclophosphamide and dexamethasone on this trial Cyclophosphamide is in a class of medications called alkylating agents It works by damaging the cells DNA and may kill cancer cells It may also lower the bodys immune response Dexamethasone is in a class of medications called corticosteroids It is used to reduce inflammation and lower the bodys immune response to help lessen the side effects of chemotherapy drugs Giving TiNK and isatuximab with standard treatment may be a safe and effective treatment for relapsed or refractory multiple myeloma
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the safety and tolerability of transforming growth factor beta imprinted natural killer cells TiNK and isatuximab in patients with multiple myeloma MM relapsed or refractory RR to BCMA-targeting therapy
SECONDARY OBJECTIVES
I To evaluate the objective response rate ORR by International Myeloma Working Group IMWG criteria of TiNK and isatuximab in patients with MM RR to BCMA-targeting therapy
II To determine the time to response TTR time to next therapy TTNT the duration of response DOR progression free survival PFS and overall survival OS at 1 year
III To determine correlatives of outcomes IV To assess quality of life QOL with therapy
OUTLINE This is a dose-escalation study of TiNK followed by a dose-expansion study
Patients receive cyclophosphamide intravenously IV on day 1 dexamethasone orally PO on days 1-4 TiNK IV on day 8 and isatuximab IV on days 8 and 15 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo bone marrow aspiration and biopsy during screening and on study as well as optionally during follow up Patients undergo echocardiography ECHO during screening and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days 60 days Patients who discontinue study treatment for reasons other than progressive disease follow up every 12 weeks for up to 2 years
I To evaluate the safety and tolerability of transforming growth factor beta imprinted natural killer cells TiNK and isatuximab in patients with multiple myeloma MM relapsed or refractory RR to BCMA-targeting therapy
SECONDARY OBJECTIVES
I To evaluate the objective response rate ORR by International Myeloma Working Group IMWG criteria of TiNK and isatuximab in patients with MM RR to BCMA-targeting therapy
II To determine the time to response TTR time to next therapy TTNT the duration of response DOR progression free survival PFS and overall survival OS at 1 year
III To determine correlatives of outcomes IV To assess quality of life QOL with therapy
OUTLINE This is a dose-escalation study of TiNK followed by a dose-expansion study
Patients receive cyclophosphamide intravenously IV on day 1 dexamethasone orally PO on days 1-4 TiNK IV on day 8 and isatuximab IV on days 8 and 15 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo bone marrow aspiration and biopsy during screening and on study as well as optionally during follow up Patients undergo echocardiography ECHO during screening and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days 60 days Patients who discontinue study treatment for reasons other than progressive disease follow up every 12 weeks for up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09969 | REGISTRY | CTRP Clinical Trial Reporting Program | None |