NCT05081479

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	N-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.

Timeline

• Start date: 2021-12-08
• Primary completion: 2026-10-21
• Completion: 2026-10-21
• First posted: 2021-10-18
• Last updated: 2025-11-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study