The time required for CAR-T cell production is shortened

Researchers at Cleveland-University Hospital Seidman Cancer Center and a biotech startup have developed a simplified method to produce CAR-T cells for immunotherapy in 24 hours, an improvement
over the team's previous standard 8 days and the 3 weeks typically taken by commercial vendors.
The team was one of
the first in the country to test this manufacturing method.

This revolutionary new advance promises to accelerate the delivery of CAR-T therapy to those who need it most – a top concern for
hematologists and oncologists and their patients.
What's more, researchers at UH Seidman Cancer Center say that rapidly manufactured CAR-T cells appear to be more efficient
than cells made by traditional methods.

Why speed matters: Some evidence suggests that 25 percent of cancer patients who plan to receive CAR-T treatment have their disease progressed before receiving treatment, and many wait more than three weeks
for commercial CAR-T products to be delivered.

Dr James Martin, an oncologist at UH Seidman Cancer Centre, added: "Some patients don't have much time, so it's important to streamline the production process and perhaps even produce more efficient products that will ultimately benefit
a lot of people.
" He is the principal investigator
of an upcoming Phase I clinical trial testing the new CAR-T manufacturing technology.

"This work by scientists at the University of Houston is of fundamental importance for the development of such products in the field of CAR-T cell therapy and other diseases such as acute leukemia or certain solid tumors in the future," said
Koen van Besien, Ph.
D.
, director of hematology at the University of Houston Seidman Cancer Center, director of the Wesleyan Center for Immunotherapy, and Don C.
Dangler Chair in Stem Cell Research.

What is CAR-T therapy?

CAR-T therapy is the mainstream
of modern immunotherapy for the treatment of certain cancers.
This process allows doctors to identify markers on the surface of cancer cells, extract the patient's own normal T cells, and reverse engineer them to specifically look for cells with suspicious markers that destroy the cancer
.
These genetically engineered cells are called chimeric antigen receptors, or CAR-T cells
.

The researchers say the new manufacturing process developed here further extends the benefits of
this breakthrough therapy.

"Faster CAR-T products appear to be more effective and effective," said David Wald, M.
D.
, associate director of basic research at the newly expanded Wesleyan Center for Immunotherapy at UH Seidman Cancer Center and associate professor of pathology at Western Reserve University School of
Medicine.
"We need to do clinical studies to be sure, but at least in animal studies, rapid CAR-T products are more effective
than cells made using traditional processes.
" This seems to have a big advantage, not only can the product be produced more efficiently and at a significantly lower cost, but we want it to be more effective
for patients as well.
”

Clinical trials will begin soon

In November, UH Seidman Cancer Center will launch a Phase I clinical trial
of a rapidly fabricated CAR-T cell product in conjunction with Case Comprehensive Cancer Center and Cleveland Clinic.
The trial will test the safety of
UF-KURE19 cells in adult patients with relapsed or refractory non-Hodgkin lymphoma.
However, if the trial is successful, the team hopes to expand testing of the rapidly manufactured CAR-T product to other types of cancer patients
.

Dr.
Wald said that rapid conditioning therapy is also being studied, so it is hoped that in the future, the time the product can be used by patients can be further improved, but as long as the use time is shortened to 4 to 5 days, it can bring clear and immediate benefits
to cancer patients.
 

Make this technology accessible to others

Dr.
Wald said that in developing this new technology, the research team is working together to make the manufacturing process simple and inexpensive so that hospitals around the world without advanced equipment can use it
.

"We are working to do this, eventually, as a therapy that can be produced outside of specialized Good Manufacturing Practice (GMP) laboratories so that it can be more suitable for most major hospitals around the world, especially in places where the complex expertise and facilities required to produce CAR-T cells themselves are currently limited and in other countries
.
" Our goal is to create a very simple, one-day process that doesn't require a lot of complicated equipment or expertise
.
”

Affects the patient

Dr.
Martin and Dr.
Van Bessian said they are optimistic about the changes the new CAR-T manufacturing process can make to patients
.

Dr Martin said: "Especially for patients with multiple relapsing invasive diseases, it is sometimes difficult to find appropriate treatments to control the condition
.
" "While waiting for a CAR-T product, the more treatment items a patient receives, the less
sensitive it is to chemotherapy.
Hospitalizing patients and providing them with cell products within a few days will have a significant and meaningful impact on
their disease control.
”

Dr van Besien added: "This will help the sickest patients among our lymphoma patients, who often do not have time to wait for the lengthy manufacturing process to receive life-saving CAR-T treatment
.
"