Making (Lots of) NK Cells

When Dean Lee, MD, PhD, joined Nationwide Children’s and The Ohio  State University Comprehensive Cancer Center in 2016, the institutions gave him leadership of a joint program: the Cellular Therapy and Cancer Immunology Program (CTCI), which serves to develop research efforts into clinical care for both pediatric and adult patients.

The CTCI team has worked hard to develop techniques to generate universal NK cell-based therapies and the ability to manufacture a wide range of other immunotherapies. They currently produce the NK cells used in their multi-site AML study and will also supply a host of other NK cell studies slated to open in nearly a dozen indications once enough cells are processed for their one-of-a-kind bank.

Manufacturing was initially established at The Ohio State University to support clinical trials at both institutions. Since the development of a dedicated Good Manufacturing Practice (GMP) facility for cellular therapy at Nationwide Children’s, known as the Cell-Based Therapy (CBT) Core, the group has begun transitioning manufacturing for most of the patient-specific and universal-donor NK cell pediatric studies to the children’s hospital.

“Having the ability to make NK cell products right here gives us rapid access for clinical studies and ensures we have oversight of the innovative processes we have underway,” says Margaret Lamb, MD, pediatric oncologist at Nationwide Children’s, who has written multiple universal-donor NK cell protocols that are FDA-approved and pending launch. The team expects to open these studies at multiple sites and ship the product to participating institutions as patients enroll. “The biggest thing is the time it saves for patients who need treatment right away — making these ourselves means we can get cells straight to patients without waiting for the donation and expansion process.”

The CRISPR/Gene Editing Core at Nationwide Children’s, also in collaboration with The Ohio State University, is led by Dr. Naeimi Kararoudi, who works with Dr. Lee and his team to drive forward multiple NK cell gene modification (knock-out and/or CAR-NK) efforts. In addition to NK cells, other cell products are also currently under study.

4
national cancer consortia funding CTCI NK cell research

4-6
weeks faster treatment using off-the-shelf NK cells

20×
as many cells as old NK cell expansion methods

50-100
patients treated per universal-donor collection

8+
cancer protocols awaiting universal-donor NK cell supply

12+
patents filed for the team’s NK cell techniques

4+
pharma companies using the team’s NK cell technology