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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT04890236
Trial Phases:		Protocol IDs:	Winship5085-20 (primary) NCI-2020-06380 STUDY00001001
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04890236

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.

Objectives

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 (CAR-T 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 therapy.
VI. To evaluate survival rates following CAR-T cell therapy.
VII. To describe the frequency of cytokine release syndrome (CRS) and neurotoxicity requiring intensive care unit (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 commercial CD19 CAR-T via infusion. Patients also undergo positron emission tomography (PET)/computed tomography (CT) scans between day -14 and day 0 and again on day 90.

Patients are followed for approximately 90 days after CAR-T infusion.

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