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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Lymphoma

Treatments: Drug: N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05081479

21-386

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Participants with Lymphoma, Cohort 1

Experimental group

Description:

The first dose escalation cohort in the study will be treated at 25% of that target dose level

Treatment:

Drug: N-Acetylcysteine

Participants with Lymphoma, Cohort 2

Experimental group

Description:

The second cohort in the study will be treated at 50% of that target dose level

Treatment:

Drug: N-Acetylcysteine

Participants with Lymphoma, Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: N-Acetylcysteine