RecruitingPhase 2NCT05757219

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

27 participants

Start Date

May 19, 2023

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving itacitinib (a JAK inhibitor that dials down certain immune signals) before CAR-T cell therapy (a type of gene-modified immune cell treatment) can improve outcomes for patients with diffuse large B-cell lymphoma (DLBCL), by potentially making the immune environment more favorable before the CAR-T cells are infused. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of DLBCL or a related variant - You are planning to receive CAR-T cell therapy (axicabtagene ciloleucel) at Moffitt Cancer Center - You are eligible for CAR-T treatment per standard criteria **You may NOT be eligible if...** - You are not eligible for CAR-T cell therapy - You have a diagnosis other than DLBCL or its variants covered by the study - You have health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGItacitinib

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.

BIOLOGICALChimeric 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.