Early detection of cognitive side effects from immunotherapy
Official title: Early Identification of Cognitive Side-Effects of Immunotherapy
Run by Masonic Cancer Center, University of Minnesota · NCT06414278 · Data updated 2026-11-12
This project tests whether an automated toolkit called SALSA can find early cognitive side effects in adults receiving CAR-T immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | CAR-T, immunotherapy, chimeric antigen receptor |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | February 8, 2024 |
| Main results expected | July 21, 2027 |
| Study ends | February 21, 2028 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT06414278 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older planning to undergo inpatient CAR-T therapy at the University of Minnesota who are fluent in English and do not have preexisting diagnosed cognitive impairment or speech/hearing impediments.
✕Probably not a fit
People with preexisting cognitive impairment, significant speech or hearing impairments, non-English speakers, or those treated outside the participating center are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project follows adults receiving commercial CAR-T therapy at the University of Minnesota who are at risk for immune effector cell–associated neurotoxicity syndrome (ICANS). Participants complete automated SALSA assessments alongside standard ICE cognitive exams at scheduled times around their inpatient CAR-T treatment, and investigators review medical records for related clinical events. SALSA captures and scores features of speech, language, affect, and stress to detect subtle cognitive changes without requiring lengthy clinician-administered tests. The design compares SALSA signals to standard assessments to determine whether automated markers appear earlier than routine evaluations.
Why it matters
Potential benefit: If successful, SALSA could identify cognitive side effects earlier than standard exams, allowing quicker clinical response and potentially reducing the severity of ICANS-related problems.
How similar studies have gone: Automated speech and language analysis has shown promise in other neurological and psychiatric conditions, but its use specifically to detect ICANS after CAR-T is still novel and has limited validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \* ≥ 18 years of age at initiation of therapy * Planning to undergo inpatient CAR-T therapy for primary malignancy * Fluent in English (written or spoken) Exclusion Criteria: * \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA * Subjects with diagnosed cognitive impairment prior to CAR-T therapy * Unwilling or unable to sign voluntary written consent
Where it's running
-
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Veronika Bachanova — Masonic Cancer Center, University of Minnesota
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.