Date: 2017-04-03
Type of
information: Clinical trial authorisation
phase: 3
Announcement: clinical trial authorization
Company: Kiadis Pharma (The Netherlands)
Product: ATIR101™ (Allodepleted T-cell ImmunotheRapeutics)
Action
mechanism:
- cell therapy/immunotherapy product. ATIR™ is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation is the only potentially curative option for many patients but a matching donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make stem cell transplantations available for patients worldwide. Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.
Disease: acute leukemia
Therapeutic
area: Cancer - Oncology
Country: Belgium, Canada, Croatia, Germany, Italy, Portugal, Spain, UK
Trial
details: (NCT02999854)
Latest
news:
- • On April 3, 2017, Kiadis Pharma announced that it has obtained regulatory approval from the national authority in Belgium (the FAGG, the Federal Agency for Medicines and Health Products) to start its randomized, controlled, transatlantic Phase III clinical trial with ATIR101™ for acute leukemia (CR-AIR-009) in Belgium. In addition, the Company has received regulatory approval from the national authority in Germany (the PEI, the Paul-Ehrlich-Institute) to start its Phase I/II clinical trial with ATIR201™ for thalassemia (CR-BD-001).
- • On February 6, 2017, following regulatory approval from Health Canada, Kiadis Pharma announced the initiation of its randomized, controlled, transatlantic Phase III trial with ATIR101™ (CR-AIR-009). Approximately 195 patients with acute leukemia will be enrolled in total in the Phase III trial and randomized 1:1 to receive a haploidentical allogeneic HSCT using either the Kiadis Pharma approach with a single dose of ATIR101™ or the post-transplant cyclophosphamide approach (also known as the Baltimore Protocol). The trial protocol has also been submitted for approval and is being evaluated by the FDA as well as several European regulatory authorities. Following approval the trial will be rolled out to additional study centers in the United States and Europe.
CTI Clinical Trial and Consulting Services, Inc., an international clinical contract research organization, has been appointed to work with Kiadis Pharma to support the clinical part of the trial and PCT, a Caladrius company, a leading external manufacturing partner to the cell therapy industry, will manufacture ATIR101™ for the United States and Canada. The German Red Cross Blood Donor Service, Baden-Wuerttemberg-Hessen, will remain the manufacturer in Europe. All 15 study centers that participated in the Company’s Phase II trials with ATIR101™ (CR-AIR-007 and CR-AIR-008) have confirmed their intention to participate in the Phase III trial (CR-AIR-009). Kiadis Pharma is actively and rapidly aligning more sites with the aim of having more than 40 sites in North America and Europe participating in the Phase III trial.
Is
general: Yes
