Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
Experimental: Pre-Modulation Treatment

Participants will receive 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)

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.

Other Names:

  • YESCARTA
  • Axi-cel

Source: View full study details on ClinicalTrials.gov

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March 8, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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