NCT04890236

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Duvelisib	Given PO
BIOLOGICAL	Tisagenlecleucel	Given via infusion

Timeline

• Start date: 2022-01-13
• Primary completion: 2024-03-20
• Completion: 2024-09-04
• First posted: 2021-05-18
• Last updated: 2025-01-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study