NeurotoxicityNCT07403812
Assessing DCog Short for Neurotoxicity in CAR-T
A study testing DCog Short in people with Neurotoxicity and Neurotoxicity Syndromes, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotoxicity, Neurotoxicity Syndromes, Hematologic Malignancy
- What is being tested?
- DCog Short
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.
- Visual acuity of 20/100 or better.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jon Arnason, MD, 617-667-9920, jarnason@bidmc.harvard.edu
Jon Arnason, MD
About this study
Official title: Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Neurotoxicity, Neurotoxicity Syndromes, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
- Being tested
- DCog Short
- Keywords
- Neurotoxicity, Neurotoxicity Syndrome, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
- Medical subject headings
- Neurotoxicity Syndromes, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCog ShortBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Cell Therapy Patients | Experimental | 40 enrolled participants will complete:
* Baseline visit
* Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30
* 90 Day follow up visit Receives: Behavioral: DCog Short |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DCog Short for Early Detection of Neurotoxicity
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%.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Specificity of DCog Short for Early Detection of Neurotoxicity
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%.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity
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.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity
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.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Raw Accuracy of DCog Short for Early Detection of Neurotoxicity
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.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Secondary outcomes (2)
Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline
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.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types
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.
Measured: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start13 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Arnason, Beth Israel Deaconess Medical Center
- Investigators
- Jon Arnason, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403812
- Sponsor's protocol ID
- 25-610
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Performance of "DCog Short", an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07403812
- Acronym / sponsor ID
- 25-610
- Conditions
- Neurotoxicity, Neurotoxicity Syndromes, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
- Keywords
- Neurotoxicity, Neurotoxicity Syndrome, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T Cell Therapy Patients | Experimental | Behavioral: DCog Short40 enrolled participants will complete: * Baseline visit * Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30 * 90 Day follow up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.
- Visual acuity of 20/100 or better.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCog ShortAn 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. | Behavioural | CAR-T Cell Therapy Patients |
Primary outcome
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%.
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%.
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.
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.
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jon Arnason, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCog Short in people with Neurotoxicity and Neurotoxicity Syndromes, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon Arnason, MD ((617) 667-9920, jarnason@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.