Patients' Willingness and Perspectives Toward Chimeric Antigen Receptor T-Regulatory Cell Therapy for Inflammatory Bowel Diseases

Abstract

Background: Inflammatory bowel disease is a life-changing disease resulting from recurrent intestinal inflammation. Current therapies (eg, steroids and biologics) are associated with mild to severe side effects, and none provide a cure. Recent research has focused on genetically engineering gut-specific anti-inflammatory T-regulatory cells (CAR-Tregs) to control intestinal inflammation, a logistically and conceptually complex approach. The purpose of our study was to understand patients' willingness to try CAR-Treg given 2 hypothetical scenarios-in a clinical trial or as a new treatment.

Methods: We surveyed people living with inflammatory bowel disease about their willingness to try CAR-Treg. The online survey was developed using patient focus groups and associated literature. We recruited participants through email and social media. We used descriptive and inferential statistics to analyze closed-ended questions and inductive thematic analysis to analyze open-ended follow-up questions.

Results: Survey participants indicated high willingness to try CAR-Treg therapy in both a clinical trial and as a new treatment. Willingness to try was not correlated with disease state or medication history. Women were less likely than men to indicate willingness to participate in a clinical trial. Participants' reasons for being willing to try CAR-Treg therapy included the wish to change their current treatment and the calling to participate in research. Participants that were not willing to try CAR-Treg mentioned the lack of long-term data and the success of their current therapy.

Conclusions: This is the first study to our knowledge to investigate patient willingness to try CAR-Treg therapy. Our results demonstrate the promise of moving this therapy into clinical practice as most patients indicated willingness to try.

Keywords: IBD; chimeric antigen receptor; patient preference; regulatory T cell; willingness to try.

FIGURE 1.

Willingness to try CAR-Treg therapy. Phase 4 indicates willingness to try CAR-Treg therapy as a new treatment that was shown to work well and is safe in people. Phase 2/3 indicates willingness to participate in a clinical trial to test the efficacy of CAR-Treg therapy after it has been shown to be safe in people. ***P < 0.0001.