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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the THRIVE-CAR-T treatment?

Research shows that CAR-T cell therapy, similar to THRIVE-CAR-T, has been effective in treating certain blood cancers like B-cell leukemia and lymphoma, with some patients experiencing long-term remission. This suggests that THRIVE-CAR-T might also be effective in treating similar conditions. ^{1 2 3 4 5}

How is the THRIVE-CAR-T App for CAR-T Cell Therapy different from other treatments?

The THRIVE-CAR-T App for CAR-T Cell Therapy is unique because it potentially allows for in situ programming of CAR T cells, which means the T cells can be engineered directly inside the patient's body, avoiding the complex and costly ex vivo manufacturing process. This approach could make CAR T cell therapy more accessible and personalized, as it may enable real-time monitoring and adjustment of the treatment to improve outcomes. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question\[s\] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.

Eligibility Criteria

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

Already participating in another supportive care clinical trial

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dual CD19/CD22 CAR T Cells Show Feasibility in Pediatric/Young Adult B-ALL. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Model-Based Cellular Kinetic Analysis of Chimeric Antigen Receptor-T Cells in Humans. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Humanized CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells in CAR-Naive and CAR-Exposed Children and Young Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A bioengineered immunocompetent human leukemia chip for preclinical screening of CAR T cell immunotherapy. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

In Situ Programming of CAR T Cells. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of CAR T cell expansion and cytotoxic potential during Ex Vivo manufacturing using image-based cytometry. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Making Better Chimeric Antigen Receptors for Adoptive T-cell Therapy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Monitoring CAR-T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges. [2022]