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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081479
• Other study ID #: 21-386
• Status: Recruiting
• Phase: Phase 1
• Start date: December 8, 2021
• Est. completion date: October 21, 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Gunjan Shah, MD
• Phone: 646-608-3734
• Email: shahg[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 21, 2025
• Est. primary completion date: October 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of N-AC	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.	Up to 1 year

External Links

•   Memorial Sloan Kettering Cancer Center