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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05081479

Enrollment

Registered

2021-10-18

Start date

2021-12-08

Completion date

2026-10-21

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

N-AC, N-Acetylcysteine, Lymphoma, CD19 CAR T-cell Therapy, 21-386, Memorial Sloan Kettering Cancer Center

Brief summary

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.

Interventions

DRUGN-Acetylcysteine

N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients \<45kg will be adjusted to weight based dosing.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum tolerated dose of N-AC	Up to 1 year	This is a phase 1 dose escalation and expansion study to determine the maximum tolerated dose and recommended phase 2 dose of NAC given in conjunction with axicabtagene ciloleucel.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026