Nilanjan Ghosh, MD, PhD: The collection process is similar for the axicabtagene ciloleucel [axi-cel], CTL019 [Kymriah], or lisocabtagene maraleucel [liso-cel]. It’s what you do after the product is collected. For axi-cel, you ship it to Kite Pharma, the company that handles axi-cel. After that, the patient is enrolled in Kite Connect, through which you can see when the product is going to be ready for delivery. For CTL019, after collection it’s cryopreserved at the site where it’s collected and then shipped to Novartis. The patient is enrolled in Kymriah Cares, through which they can see the progress of their cell delivery. For liso-cel, it’s on a clinical trial again, so the product is collected and sent to Juno Therapeutics, who receives the product fresh. Two of the products right now are shipped fresh, and 1 is cryopreserved.
Leo Gordon, MD: One of the problems with this type of therapy is, so far—at least in clinical trials, but also because of the insurance approval process for commercial use, especially in Medicare patients—is that there is a fairly long turnaround time. In clinical trials there are slots we share with our investigators from around the country, and we may have only 1 slot a month for patients. You might see a patient in September, and not have a slot available for December or January for CAR T.
If you’re talking about commercial product, you may see a patient in September and it may take a couple of months for the insurance approval to go through. There is an issue with what we do during this delay. We’ve tried to evolve a variety of different bridging therapies. It depends on what treatments they’ve had previously. We sometimes use regimens such as gemcitabine [Gemzar] and oxaliplatin [Eloxatin]. We’ve also used lenalidomide [Revlimid], and a CD20 antibody—Rituxan—and obinutuzumab [Gazyva].
That turnaround time is longer than it ultimately will be. These won’t be issues in the future, but it’s a real problem, and we’re struggling to figure out how to keep things under control.
Nilanjan Ghosh, MD, PhD: Once the cells are ready to be sent from the company, they are received by the facility where they are going to be administered. The axi-cel and CTL019 are administered at bedside. Liso-cel is sent in 2 separate vials: one is CD4-positive cells and the other is CD8-positive cells. The appropriate amount is drawn up into syringes so that the patient receives a 1:1 ratio.
Transcript Edited for Clarity