Date: 2017-02-06
Type of
information: update on patient enrollment
phase: 2
Announcement: update on patient enrollment
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: blood cancer patients for whom a matched donor is not available for a standard transplantation procedure
Therapeutic
area: Cancer - Oncology
Country: Belgium, Canada, Germany, UK
Trial
details:
- The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons. (NCT02500550)
Latest
news:
- • On February 6, 2017, Kiadis Pharma provided a progress update on the ongoing CR-AIR-008 trial with ATIR101™.
- Infusing a single dose of ATIR101™ continues to be safe in this Phase II trial (CR-AIR-008) which, as previously announced, is continuing to treat patients with a single dose of ATIR101™ according to the clinical protocol and the recommendation of the Independent Data Monitoring Committee (IDMC). Five patients in this trial have now been treated with a single dose of ATIR101™ of which three were infused more than 120 to 150 days ago. None of these patients have shown any symptoms of severe Graft-versus-Host-Disease (GVHD), with none having received any prophylactic immunosuppression.
- • On December 21, 2016, Kiadis Pharma announced an update on the second dose Phase II trial with ATIR101™ (CR-AIR-008 ). The company will continue its CR-AIR-008 trial, treating patients with a single dose of ATIR101™ according to the recommendation of the Independent Data Monitoring Committee (IDMC) and according to the clinical protocol.
In this ongoing exploratory Phase II trial the safety and efficacy of a second dose of ATIR101™ is being tested in patients to investigate product flexibility in administering a further dose of ATIR101™ should it be needed by physicians. Fifteen patients have been recruited into the trial to date of which ten have received one or two doses of ATIR101™ after their haploidentical stem cell transplantation (HSCT). All ten patients received a first dose of the same efficacious level as the patients in the Company’s other trials, and, as in the other trials with a single dose of ATIR101™, no patient suffered from grade III/IV Graft-versus-Host-Disease (GVHD) upon infusion of the first dose. Subsequently, six of the ten patients received a second dose of ATIR101™. Following this second infusion, some of the six patients subsequently suffered from various grades of GVHD, including grade III/IV GVHD.
After consultation with the IDMC, the IDMC recommended to proceed according to the predefined safety measure set out in the trial protocol, which is to continue with the trial, dosing patients with one dose of ATIR101™ at the efficacious level but not to provide a second dose of ATIR101™. Patient safety is paramount to the Company, hence it fully supports this recommendation and will continue to enroll and treat patients until 15 patients have received at least a single dose of ATIR101™. In the meantime, preparations for the Company’s Phase III trial with ATIR101™ (CR-AIR-009) are moving rapidly ahead, the trial having been submitted to regulatory authorities where it is currently under review for approval.
- • On October 20, 2015, Kiadis Pharma announced that the first patient has been enrolled into its repeat-dosing Phase II clinical trial, CR-AIR-008, with its lead product ATIR101™. The patient was enrolled in Hamilton, Canada within a month of receiving regulatory approval for the study from the Canadian authorities. In this new trial the safety and efficacy of administrating a second dose of ATIR101™ after the initial stem cell transplantation to patients with blood cancer, to further improve the outcome of their stem cell transplantation, will be studied. The study has now been approved by authorities in Canada, Belgium and the United Kingdom, with approval pending in Germany. The company also plans to expand the study to the USA pending regulatory approval. A total of 15 leukaemia patients with acute myeloid leukaemia, acute lymphoblastic leukaemia or myelodysplastic syndrome will be enrolled.
- • On September 30, 2015, Kiadis Pharma announces that it has obtained regulatory approvals from the national authorities both in Canada and in Belgium to start a further Phase II clinical trial with its lead product ATIR101™. In this new trial the safety and efficacy of using a second dose of ATIR101™ will be studied. ATIR101™ is a cell-based product designed to enable stem cell transplantations from partially matched (haploidentical) family donors for blood cancer patients who do not have a matching stem cell donor available. Previously announced results obtained in prior and ongoing clinical studies confirm the safety and efficacy of a single dose of ATIR101™ at 2×106 cells/kg, with no grade III-IV (life-threatening) acute Graft versus Host Disease occurring, despite the fact that no prophylactic immune suppressants were used. Furthermore, only limited severe infections and relapses were reported in those studies. The aim of the new Phase II trial is to test whether the administration of a second dose of ATIR101™ to a stem cell transplantation at a later point during treatment could further improve the transplantation outcome. The study will commence in Canada and Belgium and the Company plans to expand the study to the USA and other European countries pending regulatory approvals. A total of 15 leukaemia patients with acute myeloid leukaemia , acute lymphoblastic leukaemia or myelodysplastic syndrome will be enrolled. Kiadis Pharma expects to enroll the first patient into this study in Q4 2015.
Is
general: Yes
