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

Primary Objective:

To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.

Secondary Objective:

To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings

Exploratory Objective:

To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.

Inclusion criteria

To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.

Inclusion criteria

• Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
• Sexes Eligible for Study: All
• Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Patients who have already been administered CAR-T cell therapy.
• The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
• Patient has a condition which places him at an unacceptable risk as determined by the investigator