NCT05757219

Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

A Phase 2, Single-Arm, Open-Label Study Using Itacitinib as Pre-Modulation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Receiving CAR-T-Cell Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of once daily itacitinib oral administration in participants with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with axicabtagene ciloleucel (axi-cel).

Detailed description

This is a phase 2, single-arm, open-label study to assess the safety and efficacy of once daily itacitinib oral administration in patients with diffuse large B-Cell lymphoma (DLBCL) who will receive CAR-T-cell therapy with axicabtagene ciloleucel (Axi-cel) and have been found to have high levels of systemic inflammation. Approximately n=27 adult males and females, 18 years or older, who will receive treatment for diffuse large B-cell lymphoma (DLBCL) at the Moffitt Cancer Center with a ferritin level greater than 400 ng/ml and C-reactive protein (CRP) level greater than 2 mg/dl (20 mg/l) at screening will be enrolled. Study regimen will consist of itacitinib 200 mg PO QD beginning at time of apheresis approximately 4-6 weeks prior to CAR-T-cell therapy and will continue until Day 30 (30 Days Post-CAR-T-cell therapy). The exact number of days between apheresis and CAR T cell infusion may vary based on CAR T cell manufacturing turnaround. A single infusion of axi-cel therapy will be administered on Day 0. Investigators hypothesize that pre-modulation with itacitinib started approximately 4 weeks prior to CAR-T-cell therapy with axi-cel will improve patient outcomes in those patients with diffuse large B-cell lymphoma (DLBCL) who express high levels of systemic inflammation.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Itacitinib	Participants start itacitinib 200 mg PO once daily within 1-4 days after apheresis while awaiting CAR-T-cell manufacturing, which is expected to take approximately from week -4 until day -7. Patients will remain on itacitinib 200 mg PO once daily from initiation until 30 days post-CAR-T-cell therapy (Day 30) including throughout lymphodepleting chemotherapy period (Days -5, -4, -3) and axi-cel infusion (Day 0) for a total of approximately 58 doses.
BIOLOGICAL	Chimeric antigen receptor (CAR) T-cell therapy	Yescarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.

Timeline

• Start date: 2023-05-19
• Primary completion: 2026-06-20
• Completion: 2027-01-01
• First posted: 2023-03-07
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study