Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890236
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2021-05-13
Brief Title:
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma DEEP T CELLS Study
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Diffuse Large B Cell Lymphoma DEEP T CELLS
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This early phase I trial investigates how well duvelisib exposure before CAR-T cell manufacturing works to enhance immune profiles of T cells in patients with diffuse large B-cell lymphoma that has come back recurrent or does not respond to treatment refractory Duvelisib an oral phosphoinositide 3-kinase PI3K inhibitor may favorably change a patients T cells to make them more efficient and have a longer duration for manufacturing of CAR-T cells
Detailed Description:
PRIMARY OBJECTIVE
I To assess the increase in CD27CD28 T cells after 8 to 15 day exposure duvelisib prior to collection of mononuclear cells for chimeric antigen receptor T-cell CART cell manufacturing
SECONDARY OBJECTIVES
I To evaluate patient compliance with duvelisib II To evaluate the time required for manufacturing CAR-T using mononuclear cells from duvelisib-treated patients
III To describe the frequencies of CD2728 double positive T cells and CD48 double negative T cells
IV To evaluate expansion and persistence of CAR-T cells V To evaluate overall response rates following CAR-T cell therapy VITo evaluate survival rates following CAR-T cell therapy VII To describe the frequency of CRS and neurotoxicity requiring ICU transfer for CRS or neurotoxicity andor treatment VIII Describe the safety and tolerability profile of duvelisib
OUTLINE
Patients receive duvelisib orally PO twice daily BID for 2 weeks prior to collection of CAR-T cells in the absence of disease progression or unacceptable toxicity Patients then receive tisagenlecleucel via infusion
Patients are followed up 100 days after CAR-T infusion
I To assess the increase in CD27CD28 T cells after 8 to 15 day exposure duvelisib prior to collection of mononuclear cells for chimeric antigen receptor T-cell CART cell manufacturing
SECONDARY OBJECTIVES
I To evaluate patient compliance with duvelisib II To evaluate the time required for manufacturing CAR-T using mononuclear cells from duvelisib-treated patients
III To describe the frequencies of CD2728 double positive T cells and CD48 double negative T cells
IV To evaluate expansion and persistence of CAR-T cells V To evaluate overall response rates following CAR-T cell therapy VITo evaluate survival rates following CAR-T cell therapy VII To describe the frequency of CRS and neurotoxicity requiring ICU transfer for CRS or neurotoxicity andor treatment VIII Describe the safety and tolerability profile of duvelisib
OUTLINE
Patients receive duvelisib orally PO twice daily BID for 2 weeks prior to collection of CAR-T cells in the absence of disease progression or unacceptable toxicity Patients then receive tisagenlecleucel via infusion
Patients are followed up 100 days after CAR-T infusion
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 |
|---|---|---|---|
| P30CA138292 | NIH | Emory University | httpsreporternihgovquickSearchP30CA138292 |
| NCI-2020-06380 | REGISTRY | None | None |
| Winship5085-20 | OTHER | None | None |