Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study

Refractory Diffuse Large B-Cell Lymphoma Clinical Trial

Official title: Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Diffuse Large B Cell Lymphoma (DEEP T CELLS)

Status Recruiting

Clinical Trial 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 patient's T cells to make them more efficient and have a longer duration for manufacturing of CAR-T cells.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the increase in CD27+/CD28+ 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 CD27/28 double positive T cells and CD4/8 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 VI.To evaluate survival rates following CAR-T cell therapy VII. To describe the frequency of CRS and neurotoxicity requiring ICU transfer (for CRS or neurotoxicity) and/or 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. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Recurrent Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma

• NCT number: NCT04890236
• Study type: Interventional
• Source: Emory University
• Contact: Edmund Waller, MD, PhD
• Phone: 404-778-6547
• Email: ewaller@emory.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 13, 2022
• Completion date: August 27, 2025