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

Phase 1

Recruiting

• Conditions: Lymphoma
• Interventions: Drug: N-Acetylcysteine

• Registration Number: NCT05081479
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Study Start: 2021-12-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-10-21
• Study Completion: 2025-10-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Read More

Exclusion Criteria

• Patients with known allergy to N-AC

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants with Lymphoma, Cohort 1	N-Acetylcysteine	The first dose escalation cohort in the study will be treated at 25% of that target dose level
Participants with Lymphoma, Cohort 3	N-Acetylcysteine	The third cohort in the study will be treated at 100% of that target dose level only if no DLTs are seen at lower doses.
Participants with Lymphoma, Cohort 2	N-Acetylcysteine	The second cohort in the study will be treated at 50% of that target dose level

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States