Actively Recruiting
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how changes in pupil size and reaction relate to the start of neurological side effects in patients receiving CAR-T cell therapy, specifically Axi-cel (CD19 CAR-T cell) treatment. It focuses on adults with certain types of lymphoma who are treated in a hospital setting. The study is observational and seeks to assess the connection between pupil changes and neurotoxicity within 10 days after treatment, along with evaluating the severity of symptoms and safety of the measuring device. Participants will have their pupils measured using the NeurOptics4 NPi4-300 Pupillometer, a handheld, non-invasive device that scans each eye separately without touching the eye. The scanning process takes less than five minutes per session. The study will track changes in the Neurological Pupil index (NPi) from before treatment to after infusion, and also assess differences between eyes to see if these relate to symptom severity. During the study, participants will undergo regular pupil measurements and be monitored for neurological symptoms using clinical evaluations and possibly imaging or EEG tests. Researchers will record any adverse events over about one year following study participation. The study will also assess the safety and ease of using the pupillometer device in this patient group. Participants will be involved throughout this monitoring period while receiving their usual care.
CONDITIONS
Brief Title
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and above
- All genders are eligible
- Diagnosed with DLBCL, PMBCL, transformed follicular lymphoma (tFL), or follicular lymphoma
- Receiving Axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
- Able to understand and willing to sign written informed consent
You will not qualify if you...
- Patients who have already received CAR-T cell therapy
- Unwilling or unable to comply with study requirements including pupillometer assessments
- Conditions posing unacceptable risk as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo pupillometer assessments using a non-invasive device to measure both eyes before and after CAR-T cell infusion to predict neurotoxicity.
Multiple pupillometer assessments during inpatient stay and follow-up
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Ranjit Nair, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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