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The plan is to assess the safety and efficacy of the genetically engineered cell therapy alongside high-dose chemotherapy and blood stem cell transplantation in approximately 150 patients with lymphoma.
The first patient with lymphoma received treatment with AB-205 in the phase 3 E-CELERATE trial assessing the novel cell therapy with high-dose chemotherapy and blood stem cell transplantation, according to a press release from Angiocrine Bioscience, the manufacturer of the therapy.
AB-205 is a genetically engineered cell therapy that is administered intravenously and consists of allogeneic engineered human endothelial cells. It is currently being assessed in the E-CELERATE trial, in which researchers will evaluate the efficacy and safety of this cell therapy for the treatment of damaged organ vascular stem cell niches from high-dose chemotherapy. Researchers will also see whether the cell therapy can prevent the progression of severe multiorgan complications, which can potentially prolong hospitalization and can be life threatening, according to the release.
According to the trial’s ClinicalTrials.gov listing, researchers estimate to enroll 148 patients aged 40 years and older with lymphoma. Patients who will be assigned treatment with AB-205 or placebo, and both groups will be treated with standard-of-care preventive and supportive therapies. All patients enrolled in the trial will be candidates for high-dose chemotherapy and autologous hematopoietic cell transplantation.
“We are excited to initiate this pivotal phase 3 study,” said Dr. Paul Finnegan, chief executive officer of Angiocrine Bioscience, in the release. “We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program.”
Patients with lymphoma are often treated with high-dose chemotherapy followed by blood stem cell transplantation with the intention to cure, according to the trial’s ClinicalTrials.gov listing. Despite this approach, high-dose chemotherapy may cause damage to health tissues resulting in complications related to the immune system, blood, gastrointestinal systems and other organs.
The estimated study completion date for the E-CELERATE trial is January 2023, according to ClinicalTrials.gov.
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