This phase I trial tests the safety, side effects, and best dose of acetylcysteine in treating patients with lymphoma receiving standard of care CD19 chimeric antigen receptor (CAR) T-cell therapy, axicabtagene ciloleucel. Acetylcysteine is a type of drug called an antioxidant. Antioxidants protect cells by reducing reactive oxygen species (ROS) that can stress or damage them. When CAR T cells are returned to the body, they are constantly interacting with other parts of the immune system. This constant interaction increases ROS in the CAR T cells and may reduce the cells’ ability to multiply and attack cancer. Giving acetylcysteine with standard of care axicabtagene ciloleucel may prevent or reverse this reduced function in CAR T cells, leading to better outcomes in patients who receive axicabtagene ciloleucel for the treatment of lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT05081479.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Temporarily closed to accrual
Contact: Gunjan L. Shah
Phone: 646-608-3734
PRIMARY OBJECTIVES:
I. Assess the safety and tolerability of N-AC (acetylcysteine) given with axicabtagene ciloleucel.
II. Determine the maximum tolerated dose and recommended phase 2 dose of N-AC given with axicabtagene ciloleucel.
SECONDARY OBJECTIVES:
I. Assess clinical efficacy of axicabtagene ciloleucel given in conjunction with N-AC as measured by 3 and 6 month overall response (overall response rate [ORR], complete response [CR], partial response [PR], stable disease [SD]) rates, progression free survival, and duration of response.
II. Assess persistence of axicabtagene ciloleucel after N-AC in patients treated at the maximum tolerated dose (MTD)/ recommended phase II dose (RP2D).
EXPLORATORY OBJECTIVES:
I. Determine the early changes on T cell immune phenotyping by analyzing lymphocyte subsets, T naive/memory/effector panel, and T regulatory panel.
II. Evaluate cytokine profile changes including IL-6, ferritin, C-reactive protein, lactate dehydrogenase (LDH), D-dimer.
OUTLINE: This is a dose escalation study.
Beginning the day before starting axicabtagene ciloleucel, patients receive acetylcysteine intravenously (IV) continuously over 24 hours for up to 14 days in the absence of hospital discharge, disease progression, or unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorGunjan L. Shah
