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


Description

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.

Trial Eligibility

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

Study Info

Organization

Memorial Sloan Kettering Cancer Center


Primary Outcome

Maximum tolerated dose of N-AC


Outcome Timeframe Up to 1 year

NCTID NCT05081479

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2021-12-08

Completion Date 2025-10-21

Enrollment Target 32

Interventions

DRUG N-Acetylcysteine

Locations Recruiting

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

United States, New Jersey, Basking Ridge


Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

United States, New Jersey, Middletown


Memorial Sloan Kettering Bergen (Limited Protocol Activities)

United States, New Jersey, Montvale


Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

United States, New York, Commack


Memorial Sloan Kettering Westchester (Limited Protocol Activities)

United States, New York, Harrison


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