Integrated personalized cell technologies for improving health outcomes in children and adults

CLINICAL TRIALS

Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells

NCT03798301

Current Status: Enrolling Patients

PACT’s first clinical trial, a study to examine cell therapy to treat CMV infection in BMT recipients, will deploy virus-specific white blood cells to treat the potentially lethal reactivation that can occur after a bone-marrow transplant.

Cytomegalovirus (CMV) can affect one in three children by age 5 and can cause fever sore throat, fatigue and swollen glands, but for healthy people with stable immune systems the virus is usually kept in check and doesn’t cause any symptoms. It’s only when a patient’s immune system is suppressed that there is nothing to stop the virus from spreading in the body.

This type of treatment is currently the standard of care in some European countries, but is still considered experimental and is being attempted only at a few elite academic medical centers around the United States.

Full specifications of this trial are listed on Clinicaltrials.gov

Additional details for this trail can be found in this Press Release.

 

 

 

A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Kidney Transplant Recipients

NCT03950414

Current Status: Enrolling Patients

For the first time in the United States, PACT’s research team will test a personalized cell therapy to treat a common and serious complication facing kidney transplant patients. PACT will study a cutting-edge therapy to treat a viral infection faced by around 30 to 40 percent of kidney and/or pancreas transplant recipients.

The study will deploy virus-specific white blood cells to treat severe cytomegalovirus (CMV) infection after kidney transplantation. UW Health is the largest kidney and pancreas transplant program in the state, performing a majority of Wisconsin’s kidney and kidney-pancreas combined transplants with 315 in 2018.

In such patients, the infection can be fatal, and some anti-viral treatments have serious side effects, such as reducing blood counts and kidney function. Additionally, viruses can develop resistance to antiviral drugs. These factors make PACT’s new approach a potentially safe, effective treatment to stop this virus.

Additional details for this trail can be found in this Press Release.

Full specifications of this trials are listed on Clinicaltrials.gov

 

TCRa/b and CD19 Depleted HSCT for Non-Malignant Hematologic Diseases

Current Status: Not Yet Active

This clinical trial will evaluate hematopoietic stem cell transplant to treat children and young adults with various blood disorders for which transplant is currently the only possibility of cure. These disorders include inherited bone marrow failure syndromes, Myelodysplastic Syndrome, Sickle Cell Disease, Thalassemia, and Paroxysmal Nocturnal Hemoglobinuria with bone marrow failure.

Donor cells come from an HLA half-matched relative, or a closely-matched non-relative.  Some donor cells can be problematic if transplanted, such as alpha/beta T cells that can cause graft-versus-host disease, or B cells that can cause post-transplant lymphoproliferative disease.  In this study using a special technology, the unwanted cells are removed while the cells that have therapeutic benefit, such as 1) stem cells, 2) infection-fighting natural killer and gamma/delta T cells, and 3) cells that facilitate engraftment, are preserved in the transplanted “graft”.

Hematopoietic stem cell transplant, using this special technology, is anticipated to result in faster engraftment and fewer infections.