ACE CTL - A phase 1 study of using multi-virus cytotoxic t-cells following t-cell depleted allogeneic hematopoietic progenitor cell transplantation for prophylaxis against specific pathogens – Epstein Barr virus, adenovirus, and cytomegalovirus

Children’s Wisconsin is currently enrolling patients undergoing a T-cell depleted allogeneic stem cell transplant on a Phase I prophylactic immunotherapy trial, using donor derived cytotoxic T-lymphocytes.

One of our blood and marrow transplant and early-phase research physicians, Dr. Julie Talano, is the co-primary investigator of this trial. Children’s is the only site in the country where this trial is available.

Patients are eligible to participate in this study if:

• They are undergoing a T-cell depleted allogeneic hematopoietic cell transplant (HPCT) from a related or unrelated allogeneic donor.  

Patients undergoing allogeneic hematopoietic progenitor cell transplantation (HPCT) experience a period of immune deficiency, the extent of which is associated with the amount of T cells given with their transplant and the effects of immune suppressive agents used before and/or after HPCT. Patients who have undergone a specific kind of transplant, called a T-cell depleted transplant, are severely immune compromised during the early (first 100 days) post-HPCT period. The immune system can be suppressed further if the patient requires treatment to prevent or treat graft versus host disease (GVHD).  This level of immune system depression puts patients at high risk for a serious viral infection. Cytomegalovirus (CMV), Epstein Barr Virus (EBV), and Adenovirus (Ad) infections are commonly seen in such patients and can be life threatening. Several centers, including our Children's, have demonstrated it is possible to provide protective immunity to common post-HPCT viral infections in the form of adoptive T cell immunotherapy. The utility and safety of this type of study has been shown in a limited number of recent clinical trials. 

Our blood and marrow transplant program is FACT (Foundation for the Accreditation of Cellular Therapy) accredited and has performed over 1,100 bone marrow transplants.