Accelerating the new wave of CAR T therapy trials

CAR T-cell therapy, which has revolutionized the treatment of B-cell lineage hematological malignancies, is now being applied in new ways to solid tumors and various autoimmune diseases. This exciting evolution brings new hope and unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward.

While these advancements are promising, applying CAR T-cell therapy in new clinical settings presents unique challenges. For example, treating conditions like Multiple Sclerosis or Myasthenia Gravis in Neurology clinics or Systemic Lupus Erythematosus and Rheumatoid Arthritis in Rheumatology clinics requires collaboration between specialist clinics and established Oncology cell therapy infrastructure. These trials are inherently more complex, increasing stakeholder needs at the site. 

“Our expertise in mirroring the patient journey allows us to support sites, ensuring study success while maintaining patient safety and providing appropriate medical oversight,” explained Simran Padam, MD, Medical Director of Hematology, Oncology and Rare Disease at Worldwide Clinical Trials.

Patient safety is paramount

Given the potential risks associated with CAR T therapy, patient safety is of the utmost importance in these complex trials. Worldwide takes a multifaceted approach to ensuring patient safety and well-being. It starts with meticulous patient selection during the eligibility review process and continues with comprehensive medical oversight, with clear communication across all specialties.

“Non-oncology CAR T studies necessitate a multidisciplinary team, combining oncology expertise in CAR T infusion with the specialized knowledge of clinics other than oncology. This collaboration ensures successful trial management by addressing all aspects of patient care and research processes,” Dr. Padam explained.

Eligibility review time points, often unfamiliar to non-oncology physicians, require frequent communication to ensure patient eligibility at various stages. Worldwide carefully reviews protocols to balance enrollment feasibility with regulatory compliance and data integrity.

“We bridge the knowledge gap by providing expertise to sites and CRAs, outlining expectations throughout the patient/cell journey, including potential therapies and adverse events,” Dr. Padam added. In addition, the Worldwide team offers additional guidance on monitoring, reporting and managing side effects, including recommended treatment options not explicitly mentioned in the study protocol. 

“Our team carefully assesses each patient’s health to identify and manage potential adverse events proactively. Additionally, we offer 24/7 access to our medical monitors, giving sites direct access for questions or guidance, ensuring timely intervention. Sites can reach anyone on the team via email or phone.” 

Worldwide’s commitment to comprehensive 360-degree training further ensures that its teams, from CRAs to medical monitors, are equipped to maintain high data quality, prioritize patient safety and execute trials efficiently.

“Comprehensive medical oversight is especially critical after infusion when acute toxicities arise. Our team reviews labs, imaging, biomarkers and other relevant data to identify and address adverse events promptly. We also help sites prepare for the unexpected by ensuring access to necessary supportive treatments,” Dr. Padam explained.

Strong relationships for optimized operational planning

Engaging with experienced sites early in the process is crucial, especially as top-tier sites are busier than ever. To navigate these complexities, Worldwide actively maintains a reciprocal dialogue with a network of large academic centers and community hospitals, a robust and formalized Global Site Alliance network.

“At Worldwide, our teams are actively involved in numerous autologous and allogeneic CAR T development programs, giving us firsthand experience and a deep understanding of trial demands on patients and the sites conducting them,” Dr. Padam explained. 

This combination of experience and curated relationships is one of many reasons CAR T developers partner with Worldwide. For example, CAR T programs can benefit from rapid and candid site feedback through these protected communication channels, enabling Worldwide to proactively address potential challenges and refine operational plans. That is where the transparency and trust of an ongoing relationship make all the difference.

This distinctive approach ensures that the upcoming study is matched to the sites best positioned for success, creating a win-win for both site performance and study timelines. The Worldwide Global Site Alliance includes a spectrum of sites, ranging from experienced CAR T development veterans to those with newly acquired capabilities. By tailoring site selection to the specific needs of each study, CAR T trials can be accelerated and optimized for success

Patient-centricity is a priority

Worldwide recognizes that each patient entering a CAR T trial encounters a novel experience. This understanding drives Worldwide’s commitment to providing comprehensive support and clear communication throughout the trial journey. The need for approachable patient education materials is particularly crucial for chronic disease patient communities, especially as CAR T therapy expands into new therapeutic areas.

Sites especially appreciate the tools to support informed consent discussions. Patient understanding is also critical to study retention, which is always an area of concern for the required long-term follow-up data collection. Producing study-specific IRB-approved patient educational material improves adherence, outcomes, trust and communication.

“Patient education is critical because patients who can better understand their treatment can better manage their disease, reduce complications and maintain better overall health and quality of life,” Dr. Padam explained.

The future of CAR T-cell therapy is bright, with exciting advancements expanding its reach beyond blood cancers and exploring enhanced designs, gene editing, off-the-shelf options, combination therapies and improved safety profiles.

Partner with Worldwide and advance the frontiers of CAR T therapy. Contact us today to discuss how we can work together to achieve your research objectives and expedite the delivery of innovative treatments to patients globally.

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