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
1 other identifier
interventional
9
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lymphoma
Started Dec 2021
Typical duration for phase_1 lymphoma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 21, 2026
November 4, 2025
November 1, 2025
4.9 years
October 5, 2021
November 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Participants with Lymphoma, Cohort 1
EXPERIMENTALThe first dose escalation cohort in the study will be treated at 25% of that target dose level
Participants with Lymphoma, Cohort 2
EXPERIMENTALThe second cohort in the study will be treated at 50% of that target dose level
Participants with Lymphoma, Cohort 3
EXPERIMENTALThe third cohort in the study will be treated at 100% of that target dose level only if no DLTs are seen at lower doses.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with known allergy to N-AC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunjan Shah, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
October 18, 2021
Study Start
December 8, 2021
Primary Completion (Estimated)
October 21, 2026
Study Completion (Estimated)
October 21, 2026
Last Updated
November 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.