THRIVE-CAR-T App for CAR-T Cell Therapy

(THRIVE-CAR-T Trial)

Overseen By Patrick C Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Patrick C. Johnson, MD

Disqualifiers: Impaired cognition, Uncontrolled mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called THRIVE-CAR-T to determine its effectiveness for individuals receiving CAR-T cell therapy, a treatment for certain blood cancers. The researchers aim to learn if patients find the app helpful and easy to use during their treatment. Participants will either use the app alongside regular care or receive only regular care, which includes guidance from a nurse and written instructions. Suitable candidates for this trial are those diagnosed with a blood cancer and planning to receive CAR-T therapy at Massachusetts General Hospital. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance their treatment experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a mobile app for patients undergoing CAR-T cell therapy.

What prior data suggests that the THRIVE-CAR-T app is safe for patients undergoing CAR-T cell therapy?

A previous study tested the THRIVE-CAR-T app to determine its ease of use and helpfulness for patients receiving CAR-T cell therapy. This app is a digital tool designed to support patients, without affecting the safety of the CAR-T cell therapy itself.

CAR-T cell therapy, the main treatment in this study, has undergone thorough research. Studies have shown that approved CAR-T therapies are safe and effective for certain blood cancers. However, the therapy can cause side effects like fever or low blood pressure, which healthcare teams typically manage.

In summary, the THRIVE-CAR-T app serves as a supportive tool without its own safety risks. Its primary purpose is to enhance patient care during CAR-T therapy, which has a well-established safety record from extensive research and approved uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE-CAR-T app because it integrates digital technology with existing CAR-T cell therapy, aiming to enhance patient care. Unlike the standard approach, which involves a teaching session with a nurse and written materials, this app provides a digital platform to support patients throughout their treatment journey. The app's potential to improve patient understanding, engagement, and adherence to treatment plans makes it a promising addition to CAR-T therapy, possibly improving overall outcomes.

What evidence suggests that the THRIVE-CAR-T app is effective for patients undergoing CAR-T cell therapy?

Research has shown that CAR-T cell therapy can be highly effective for certain cancers, such as B-cell acute lymphoblastic leukemia. One study found that 83% of patients experienced complete remission after receiving CAR-T cells targeting a specific protein, meaning the cancer disappeared entirely for most patients. Additionally, long-term data indicate that this treatment can maintain cancer remission for an extended period. In this trial, some participants will receive usual care, while others will receive the THRIVE-CAR-T app in addition to usual care. Although the THRIVE-CAR-T app is new and focuses on supporting patients using CAR-T, the therapy itself has demonstrated strong promise in combating cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients undergoing CAR-T cell therapy. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I have been diagnosed with a blood cancer.

Ability to understand English

I am getting CAR-T therapy at MGH with an approved treatment.

Exclusion Criteria

Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment

Already participating in another supportive care clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAR-T cell therapy and use the THRIVE-CAR-T digital application

90 days

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, anxiety, PTSD, and other measures

90 days

Usability Assessment

Usability of the THRIVE-CAR-T app is assessed using the system usability scale

30 days

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE-CAR-T

Trial Overview The THRIVE-CAR-T digital app is being tested in this clinical trial. The focus is to determine if using the app is practical and satisfactory for patients receiving CAR-T cell therapy.

How Is the Trial Designed?

Group I: THRIVE-CAR-T plus usual care Experimental Treatment 1 Intervention

Patients receiving the THRIVE-CAR-T intervention will receive usual care and will use the THRIVE-CAR-T digital application on an iPad when planned to receive CAR-T.

Group II: Usual Care Active Control 1 Intervention

Usual care at our institution involves a teaching visit with a nurse navigator and written handouts.

Who Is Running the Clinical Trial?

Patrick C. Johnson, MD

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

In a phase 1 trial of 53 adults with relapsed B-cell acute lymphoblastic leukemia, 83% achieved complete remission after receiving CD19-specific CAR T cells, indicating high initial efficacy.

Patients with a low disease burden before treatment experienced significantly longer overall survival (20.1 months) and fewer severe side effects, such as cytokine release syndrome, compared to those with a higher disease burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. Park, JH., Rivière, I., Gonen, M., et al.[2023]

CAR T-cell therapy has shown durable remission in B-cell leukemia and lymphoma, highlighting its potential effectiveness for treating other types of cancers.

Recent advancements in CAR design and clinical application strategies aim to enhance T-cell proliferation and efficacy while minimizing toxicity, making this therapy more accessible to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T-Cells: New Approaches to Improve Their Efficacy and Reduce Toxicity. Maus, MV., Powell, DJ.[2018]

CAR T-cell therapy, particularly targeting CD19, has shown remarkable efficacy with approximately 90% complete response rates in patients with relapsed or refractory acute lymphoblastic leukemia, demonstrating its potential as a powerful treatment for B-cell malignancies.

Ongoing research is focused on enhancing the safety and effectiveness of CAR T cells, including exploring their use in solid tumors and in combination with other therapies, indicating a promising future for this innovative cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making Better Chimeric Antigen Receptors for Adoptive T-cell Therapy. Maus, MV., June, CH.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06665295?cond=car-t&viewType=Table&rank=3

Study Details | NCT06665295 | THRIVE-CAR-T Digital App This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) ...

2. withpower.com withpower.com/trial/phase-car-t-cell-therapy-10-2024-285aa

THRIVE-CAR-T App for CAR-T Cell Therapy In a phase 1 trial of 53 adults with relapsed B-cell acute lymphoblastic leukemia, 83% achieved complete remission after receiving CD19-specific CAR T cells, ...

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

Long-term outcomes following CAR T cell therapy The data demonstrate that CD19-targeted CAR T cells can induce prolonged remissions in patients with B cell malignancies, often with minimal long-term ...

4. nature.com nature.com/articles/s41392-025-02269-w

CAR-T cell therapy for cancer: current challenges and ... Among those patients who received the recommended dose, the 3-year overall survival and event-free survival were 60% and 36%, respectively. The ...

5. 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 ...

6. youtube.com youtube.com/watch?v=JOZV-i9i8Uo

Thrive | Advice for Managing Potential CAR T-Cell Therapy ... Dr. Adriana Rossi, a myeloma expert and researcher, discusses how CAR T-cell therapy has revolutionized care, the process for undergoing ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39104200/

Approved CAR-T therapies have reproducible efficacy and ... CAR-T cell therapy has established itself as a highly effective treatment for hematological malignancies. There are currently six commercial ...

8. arpa-h.gov arpa-h.gov/explore-funding/programs/thrive/teaming

THRIVE Teaming Profiles Our programs span in-vivo CAR-T and autoimmune therapies, rare disease gene correction, HIV-neutralizing antibodies, and engineered B-cells producing complex ...