Clinical trial · Interventional
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
NCT05081479CI-TRIAL-00096969active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-Acetylcysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Participants with Lymphoma, Cohort 1
- description
- The first dose escalation cohort in the study will be treated at 25% of that target dose level
- interventionNames
- Drug: N-Acetylcysteine
- type
- EXPERIMENTAL
- label
- Participants with Lymphoma, Cohort 2
- description
- The second cohort in the study will be treated at 50% of that target dose level
- interventionNames
- Drug: N-Acetylcysteine
- type
- EXPERIMENTAL
- label
- Participants with Lymphoma, Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.