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Clinical Trial Summary

To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06144151
Study type Observational
Source M.D. Anderson Cancer Center
Contact Ranjit Nair, MD
Phone (713) 563-4354
Email rnair@mdanderson.org
Status Not yet recruiting
Phase
Start date March 31, 2024
Completion date April 1, 2027

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