Voice Monitoring for CAR T-Cell Therapy Side Effects in Lymphoma and Multiple Myeloma

Not yet recruiting at 7 trial locations

Overseen By Roni Shouval, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: CAR T-cell therapy

Disqualifiers: Neurological conditions, Speech disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether voice recordings and daily nervous system checks can help detect side effects from CAR T-cell therapy, a treatment for certain blood cancers like non-Hodgkin lymphoma and multiple myeloma. Participants must record their voice twice daily and perform daily nervous system tasks using a smartphone. It suits those diagnosed with these cancers, who are set to receive CAR T-cell therapy, can speak English, and have no major speech or hearing problems. As an unphased trial, it provides a unique opportunity to contribute to innovative research that may enhance patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this monitoring method is safe for patients with lymphoma and multiple myeloma?

Research shows that CAR T-cell therapy has some known safety concerns but is generally well-tolerated. In studies with patients who have non-Hodgkin lymphoma, the chance of serious problems unrelated to cancer recurrence is about 5% to 10%. This indicates that most patients do not experience these severe issues.

Common side effects include fever, tiredness, and changes in the nervous system, which can vary in intensity. These effects are usually manageable and closely monitored by healthcare professionals.

Overall, while risks exist, the treatment has benefited many people, especially those unresponsive to other treatments. Discuss possible side effects with your healthcare team before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to monitor side effects of CAR T-cell therapy, a cutting-edge treatment for non-Hodgkin lymphoma and multiple myeloma. Unlike traditional chemotherapy or radiation, CAR T-cell therapy harnesses the body's own immune cells, which are modified to better recognize and attack cancer cells. This trial specifically investigates using voice monitoring as a non-invasive, innovative method to detect side effects early, potentially improving patient outcomes and quality of life. By focusing on real-time monitoring, this approach could lead to more personalized and timely management of side effects, setting it apart from current monitoring methods.

What evidence suggests that voice monitoring is effective for detecting side effects in CAR T-cell therapy?

Research has shown that CAR T-cell therapy holds promise for treating non-Hodgkin lymphoma and multiple myeloma. In earlier studies, about 55% of patients achieved complete remission, with no detectable cancer. Impressively, 60% of those who reached complete remission remained cancer-free even after five years. Another study found that CAR T-cell therapy improved the quality of life for patients with non-Hodgkin lymphoma. These findings suggest that CAR T-cell therapy can effectively treat these cancers. Participants in this trial will undergo monitoring for side effects using voice monitoring technology. ^{1 5 6 7}

Who Is on the Research Team?

Roni Shouval, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with non-Hodgkin lymphoma or multiple myeloma who are undergoing CAR T-cell therapy. It aims to see if voice recordings can help monitor side effects related to the nervous system.

Inclusion Criteria

Smartphone ownership

Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator

Sufficient English proficiency to complete structured voice tasks in the study application

Exclusion Criteria

Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliable task completion or data interpretation will be excluded.

I do not have any neurological conditions that majorly affect my speech.

I have no history of major speech or voice disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard CAR T-cell therapy and provide voice recordings and neurocognitive assessments

30 days

Daily voice recordings and neurocognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAR T-cell Therapy

Trial Overview

The study is testing whether voice recordings and neurologic assessments are effective in monitoring for ICANS, a potential side effect of CAR T-cell therapy, by seeing how many participants can complete these tasks.

How Is the Trial Designed?

Group I: Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma Experimental Treatment 1 Intervention

Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10100620/

Long-term outcomes following CAR T cell therapy

This study demonstrated a CR rate of 55%, and 60% of these patients remained in remission at 5 years. Overall, these results demonstrate that ...

2.

nature.com

nature.com/articles/s41408-025-01419-1

Outcomes of CAR T-Cell therapy in relapsed/refractory ...

Although racial differences in CAR T outcomes have been studied, most available data pertain to non-Hodgkin lymphoma and B-cell acute ...

3.

astctjournal.org

astctjournal.org/article/S2666-6367(25)01462-9/fulltext

Patient-Reported Outcomes of CAR T-Cell Therapy in Non- ...

This study demonstrates that CAR T-cell therapy improves overall HRQoL in NHL patients across different countries in the real-world setting.

4.

ashpublications.org

ashpublications.org/blood/article/146/14/1677/537756/Remission-conversion-drives-outcomes-after-CAR-T

Remission conversion drives outcomes after CAR T-cell ...

Cilta-cel also led to higher complete response (CR; 61% vs 39%) and improved response conversion, with more patients achieving CR after starting ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38582666/

Safety and Toxicity Profiles of CAR T Cell Therapy in Non- ...

This study serves as the first to delineate toxicity profiles associated with various available CAR T products.

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2830583

Adverse Events After CAR T-Cell Therapy in B-Cell Non- ...

The risk of nonrelapse mortality (NRM) after CAR T-cell therapy among patients with relapsed or refractory LBCL is approximately 5% to 10%, ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2152265024000661

Safety and Toxicity Profiles of CAR T Cell Therapy in Non- ...

The application of CD19-directed chimeric antigen receptor T (CAR T) cell therapy has improved outcomes for thousands of patients with non-Hodgkin B cell ...