Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 19, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Diffuse Large B Cell Lymphoma
Interventions
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.

Trial Locations (1)

33617

RECRUITING

Moffitt Cancer Center, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER