Behind the Scenes of a CAR T-Cell Trial

What do you do as a clinical research coordinator?

The primary duty is to facilitate the bridge between the clinical trial sponsor -- which can be an industry partner, an investigator, or an institution like CU – and the clinical care of patients. We coordinate between the two to ensure that all points of interest and outcomes are accounted for from the sponsor side, while prioritizing patient care and treatment. At times, a sponsor requires additional tests that a clinician might not normally request, so we ensure these needs are met. In addition to patient-facing and clinical tasks, we also manage administrative tasks such as query resolution, scheduling, and trial start-up.

What does it take to set up a clinical trial, and how does a CAR T-cell trial differ?

It varies depending on whether it’s a sponsor-initiated or investigator-initiated trial, but once a doctor at CU Anschutz agrees to be a principal investigator (PI), CRCs get involved to determine how to conduct the trial. We work with the PI to determine how to identify study participants who meet the criteria.

The big difference for CAR T trials is the timeline, as there are a lot of moving pieces. Time is built in for apheresis – the process of drawing the patient’s blood and genetically engineering T cells, which takes about two weeks. It requires constant communication to all groups of stakeholders to ensure everyone is on the same page.

To enroll in a CAR T-cell trial, the patient has typically failed two lines of therapy. They have aggressive disease and a short time to get therapy. Furthermore, there are numerous risks associated with CAR T-cell therapy, and we encourage patients to ask the CAR T coordinating team any questions they might have. As with other trials, we typically follow the patients closely for two years and then less frequently afterwards. All visits are coordinated by our team and we follow in the background to document any adverse events or changes in medication.

The CAR T patients have been really personable; they understand that this likely is a last line of therapy in hopes of remission. Patients are typically aware of treatment options and are more willing to place their faith in CAR T and the clinical team. They’ve been through the ringer, and have cleared their schedules for the treatment, which makes the process a whole lot easier.

What are the most common questions patients have about CAR T-cell therapy?

In general, the patients have already done their own homework. They’ve had other lines of therapy. Usually, their questions are very precise about what side effects to expect or they want to know whether the trial will consume their lives. Sometimes they ask if they might be assigned to a control group to receive a placebo, but in CAR trials, they are all getting their own genetically modified cells, manufactured at Gates Biomanufacturing Facility.

Patients may have a tendency to think of CAR T as a magical cure-all, but the clinicians here do a good job of managing their expectations.

What motivates you the most?

My primary motivation is our patient population! Despite their situation, they are some of the most gracious, appreciative, and lively patients. Forming bonds with the patients as well as the family members and friends makes the long and sometimes frustrating days well worth it in the end. We also get the opportunity to work alongside extremely knowledgeable staff, which makes learning seamless and fluid.