A Study of N-Acetylcysteine (N-AC) in People Receiving CAR T-cell Therapy for Lymphoma

Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma

The purpose of this study is to test the safety of N-AC when given in combination with Yescarta to people with lymphoma. This study will test different doses of N-AC to find the highest dose that causes few or mild side effects in participants.

Inclusion Criteria:

• Patients must be 18 years of age or older

• Patients who will receive axicabtagene ciloleucel for treatment of lymphoma

• Patients must have adequate end organ function to be eligible for this study as defined by the following criteria:

  • ECOG performance status 0-2
  • Hematologic function with ANC ≥ 1000, Hgb ≥ 8, Plt ≥ 50k unless there is disease related hematologic toxicity
  • Renal function with CrCr ≥ 40 ml/min or Cr ≤ 1.5 x ULN
  • Hepatic function with ALT/AST ≤ 2.5 x ULN, TBili ≤ 1.5 x ULN.

Exclusion Criteria:

• Patients with known allergy to N-AC