What is this study trying to find out about neurotoxicity?

This study is investigating how changes in pupil size and reactivity relate to neurological side effects after CAR-T cell therapy in lymphoma patients. Researchers want to understand if pupil measurements can help predict neurotoxicity early. The study is led by M.D. Anderson Cancer Center and focuses on improving monitoring after this treatment.

Who may be eligible for this neurotoxicity clinical trial?

Adults 18 years and older with certain types of lymphoma such as DLBCL, PMBCL, tFL, or follicular lymphoma who are receiving axi-cel CAR-T cell therapy may be eligible. All sexes can participate, but those already treated with CAR-T therapy or who cannot be assessed with a pupillometer are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this neurotoxicity clinical trial?

Study-related care, including use of the pupillometer and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years +

All Genders

ID06144151

Pilot Study Using Pupillometer to Predict Neurotoxicity After Axi-cel CAR-T Cell Therapy in Adults with Certain Lymphomas

Led by M.D. Anderson Cancer Center · Updated on 2026-07-16

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring how changes in pupil size and reactivity relate to the start of neurological side effects in patients after receiving CAR-T cell therapy for certain types of lymphoma. The study aims to assess if changes in the Neurological Pupil index NPi after treatment with Axi-cel CD19 CAR-T cell therapy are linked to the onset of immune effector cell-associated neurotoxicity within 10 days. They also want to see if differences in NPi between eyes relate to the severity of symptoms and brain imaging or EEG findings, and to check the safety and feasibility of using a pupillometer device during treatment. Participants will be observed using the NeurOptics NPi-300 Pupillometer, a handheld, non-invasive device placed near the cheek to scan each eye without touching it. Scanning both eyes takes less than 5 minutes each time. The study is observational and involves no drug or treatment intervention. The pupillometer readings will be collected before and after CAR-T cell therapy to assess pupil changes. During the study, participants will undergo pupil assessments with the pupillometer and have clinical evaluations including symptom scoring and possible brain imaging or EEG. Researchers will monitor the occurrence and severity of neurological side effects and record any adverse events using standardized criteria. The study expects to follow participants for about one year to collect safety data and measure outcomes related to neurotoxicity after CAR-T cell therapy.

CONDITIONS

Brief Title

A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years and older
All sexes are eligible
Patients with confirmed diagnosis of DLBCL, PMBCL, tFL, or follicular lymphoma receiving axi-cel CAR-T cell therapy as inpatients at MD Anderson Cancer Center
Ability to understand and willing to sign informed consent

You will not qualify if you...

Patients who have already received CAR-T cell therapy
Patients unwilling or unable to comply with study requirements, including pupillometer assessment
Patients with medical conditions posing unacceptable risk as determined by the investigator

Research Team

Ranjit Nair, MD

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