Recruiting

DCog Short

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07403812

Conditions

Neurotoxicity

Neurotoxicity Syndromes

Hematologic Malignancy

Immune Effector Cell Associated Neurotoxicity Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DCog Short

Study Details

Brief 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.

Conditions

Neurotoxicity

Neurotoxicity Syndromes

Hematologic Malignancy

Immune Effector Cell Associated Neurotoxicity Syndrome

Study ID

NCT07403812

Start date

Apr 13, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CAR-T Cell Therapy Patients

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

Interventions

DCog Short

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 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Jon Arnason, MD

(617) 667-9920jarnason@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jon Arnason, MD

617-667-9920jarnason@bidmc.harvard.edu

Principal Investigator:

Jon Arnason, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Neurotoxicity
  • Neurotoxicity Syndrome
  • Hematologic Malignancy
  • Immune Effector Cell Associated Neurotoxicity Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.