Recruiting

I-CAN with CAR-T

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07609030

Conditions

Recurrent B-Cell Non-Hodgkin Lymphoma

Recurrent Multiple Myeloma

Refractory B-Cell Non-Hodgkin Lymphoma

Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cognitive Intervention

Electronic Health Record Review

Survey Administration

Study Details

Brief summary:

This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity \[I-CAN\]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Cancer treatment can have significant short and long-term side effects, including cognitive and neurological side effects such as impairments in attention, memory, language, and executive function. The I-CAN program is a form of cognitive training. Cognitive training is a therapeutic approach designed to improve and restore cognitive functioning, based on the brain's ability to reorganize and form new neural connections to accomplish tasks. I-CAN provides five core elements necessary for training the brain to create new neural connections including speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.

Conditions

Recurrent B-Cell Non-Hodgkin Lymphoma

Recurrent Multiple Myeloma

Refractory B-Cell Non-Hodgkin Lymphoma

Refractory Multiple Myeloma

Study ID

NCT07609030

Start date

Apr 28, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients >= 18 years of age
  • Diagnosed with relapsed/refractory multiple myeloma (MM) or B-cell non-Hodgkin lymphoma (B-NHL)
  • Expected to receive an Food and Drug administration (FDA)-approved CAR-T cellular treatment
  • English literacy

Exclusion Criteria:

  • Patients expected to live < 6 months
  • Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery
  • Confirmed Alzheimer disease or other dementia
  • Previous central nervous system (CNS) radiation
  • Active intrathecal therapy at time of enrollment

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (I-CAN)

Patients participate in online I-CAN training sessions over approximately 2.5 hours per week for 4 weeks before and 4 weeks after CAR-T therapy for a total of 20 hours over 8 weeks. Patients also undergo collection of blood samples throughout the study.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Cognitive Intervention

Participate in I-CAN training sessions

Electronic Health Record Review

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) [ Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) ]
  • Retention [ Time Frame: 12 months post-infusion, up to 14 months ]
  • I-CAN satisfaction (feasibility) [ Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Ashley E. Rosko, MD

614-688-7397Ashley.Rosko@osumc.edu

Principal Investigator:

Ashley E. Rosko, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-05-27.