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NCT Number: NCT07403812

Assessing DCog Short for Neurotoxicity in CAR-T

The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.

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Key information

Conditions

Neurotoxicity Chemically-Induced Disorders Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Immune Effector Cell Associated Neurotoxicity Syndrome Neoplasms Neoplasms by Site Nervous System Diseases Neurotoxicity Syndromes Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location contact

Jon Arnason, MD

CONTACT

[email protected]

(617) 667-9920

Jon Arnason, MD

PRINCIPAL_INVESTIGATOR

About this study

The goal of this pilot study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy. This is the first time investigators are examining this tool.

The U.S. Food and Drug Administration (FDA) has not approved DCOG Short as a mobile application tool to evaluate neurotoxicity for hematologic malignancies.

The research study procedures include screening for eligibility, questionnaires, and cognitive assessments.

It is expected that about 40 people will take part in this research study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.
  • Visual acuity of 20/100 or better.

Exclusion criteria

  • patients < 18 years old
  • pregnant women
  • prisoners
  • adults unable to consent,
  • participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad

Treatment and study plan

DCog Short

Behavioral

An iPad-based cognitive assessment instrument to evaluate neurotoxicity and consisting of a series of tests that measure various aspects of cognitive function. After hospital discharge, participants will be provided with iPads which will be returned at the 90 day follow up visit.

Primary outcomes

  1. Sensitivity of DCog Short for Early Detection of Neurotoxicity

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to detect neurotoxicity on or before the onset of clinically confirmed ICANS. Sensitivity is defined as the proportion of patients with clinically confirmed ICANS for whom DCog Short indicates neurotoxicity on or before ICANS onset. DCog Short will be considered effective if sensitivity is ≥75% and non-promising if sensitivity is <50%.

  2. Specificity of DCog Short for Early Detection of Neurotoxicity

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Specificity is defined as the proportion of patients who do not develop clinically confirmed ICANS and are not indicated by DCog Short. DCog Short will be considered effective if specificity is ≥75% and non-promising if specificity is <50%.

  3. Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Positive predictive value is defined as the proportion of patients indicated by DCog Short who subsequently develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.

  4. Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Negative predictive value is defined as the proportion of patients not indicated by DCog Short who do not develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.

  5. Raw Accuracy of DCog Short for Early Detection of Neurotoxicity

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Raw accuracy is defined as the proportion of patients correctly classified by DCog Short, including both patients who develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and those who do not, based on standard clinical assessment.

Secondary outcomes

  1. Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    For ICANS detection and monitoring, the Immune Effector Cell-Associated Encephalopathy (ICE) score, also called CARTOX-10, will be used. The total score ranges from 0 to 10, with higher scores indicating normal cognitive function. Detailed scoring instructions and grading criteria are provided in Appendix A of the protocol.

  2. Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types

    Time frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

    Neurotoxicity will be monitored using DCog Short and CARTOX-10 assessments throughout the study period. Immune Effector Cell-Associated Encephalopathy (ICE) score, e ranges from 0 to 10, with higher scores indicating normal cognitive function. Detailed scoring instructions and grading criteria are provided in Appendix A of the protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Jon Arnason, MD

CONTACT

[email protected]

(617) 667-9920

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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