Children’s National Health System
touted data today from a Phase I dose-ranging study evaluating a cell therapy approach in patients with blood and bone marrow cancers for whom stem cell transplantation hasn’t worked.
Results from the Resolve trial showed that 78% of patients responded to multi-tumor-associated antigen specific lymphocytes (TAA-L) treatment and 44% of patients had complete remission with limited toxicity, according to Children’s National.
“These initial findings suggest that non-genetically engineered antigen-specific lymphocytes can be isolated, expanded and adoptively transferred to severely ill patients with active disease and positively impact tumor regression,” co-principal investigator Dr. Catherine Bollard said in prepared remarks. “We are encouraged by the promise of these data, which support similar efforts to exploit the immunotherapeutic potential of the natural T-cell repertoire.”
The novel cell therapy approach includes introducing a natural T-cell subtype, TAA-L, to high-risk patients with advanced blood cancers, such as acute myeloid leukemia. The study evaluated the safety and efficacy of donor and patient-derived TAA-L to patients with a variety of hematologic cancers in active diesease relapse pre- or post-allogenic hematopoietic stem cell transplantation.
The trial enrolled 10 patients and observed that ex vivo manufactured TAA-L could be successfully isolated and safely infused to patients after disease relapse.
There were no cases of graft-versus-host disease or other autoimmune-mediated toxicity, according to Children’s National, and the researchers did not observe any neurotoxicity associated with the cell therapy.
Last year, Celsion (NSDQ:CLSN) and Children’s National said that the groups are teaming up to tackle refractory solid tumors in pediatric patients using a heat-activated chemotherapy drug and noninvasive ultrasound. The Phase I clinical trial, which launched last November, is the 1st of its kind in the U.S.
Lawrenceville, N.J.-based Celsion’s ThermoDox is a heat-activated liposomal doxorubicin. In combination with MRI, high-intensity focused ultrasound is used to direct sound wave energy and heat the tumor. When the liposomal chemotherapy drug comes into contact with the heated tumor, the liposome changes structure and releases doxorubicin into the tumor.
The study, supported by the National Institutes of Health, is designed to determine the appropriate dose range of ThermoDox for pediatric patients with refractory solid tumors.
