Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550141
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Emapalumab Prevention of CAR-T Cell Associated Toxicities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkins lymphoma NHL
The research study involves the following study interventions
Fludarabine and cyclophosphamide Lymphodepleting Chemotherapy
Axicabtagene Ciloleucel
Emapalumab
The research study involves the following study interventions
Fludarabine and cyclophosphamide Lymphodepleting Chemotherapy
Axicabtagene Ciloleucel
Emapalumab
Detailed Description:
This is a phase 2 multi-center open label study that is evaluating the safety and efficacy of emapalumab in preventing toxicities associated with axicabtagene ciloleucel in subjects with second- or third-line large B-cell non-Hodgkins lymphoma
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved emapalumab for the participants specific disease but it has been approved for other uses
The US FDA has approved axicabtagene ciloleucel for the participants specific disease
This research study procedures include screening for eligibility study treatment including collection of T cells leukapheresis lymphodepleting chemotherapy treatment with emapalumab and axicabtagene ciloleucel and follow-up evaluations
Once study treatment is completed the participants will be followed for up to 24 months
It is expected that about 28 people will take part in this research study
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved emapalumab for the participants specific disease but it has been approved for other uses
The US FDA has approved axicabtagene ciloleucel for the participants specific disease
This research study procedures include screening for eligibility study treatment including collection of T cells leukapheresis lymphodepleting chemotherapy treatment with emapalumab and axicabtagene ciloleucel and follow-up evaluations
Once study treatment is completed the participants will be followed for up to 24 months
It is expected that about 28 people will take part in this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None