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Clinical Trials

Please note our product candidates are not yet available or approved for use.

We are developing our products in a tightly regulated environment of clinical studies that are reviewed and approved by the national respective authorities to establish a maximum safety level for patients. Currently, therefore, access to our investigational cell therapy is limited to patients meeting the eligibility criteria of our clinical trials.

Our lead product candidate ATIR101™ is currently being evaluated in the following clinical trials:

Clinical trial: CR-AIR-007

An exploratory, open label, multicenter study to evaluate the safety and efficacy of ATIR101, donor T-lymphocytes depleted ex vivo of host alloreactive T-cells, in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor.

Status: Study is ongoing, fully enrolled, the primary endpoint has been reached and 1 year data has been presented at ASH 2016.

Clinical trial: CR-AIR-008

An exploratory, open label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor.

Status: Study is ongoing, continuing to treat patients with a single dose of ATIR101 according to protocol and as previously announced, actively enrolling and treating patients.

Clinical trial: CR-AIR-009

A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor and adjunctive treatment with ATIR101, a T-lymphocyte enriched eukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclphosphamide in patients with a hematologic malignancy (HATCY study).

Status: Study is initiated, with regulatory approvals having been received in various countries.

Clinical trial: CR-BD-001

An exploratory, open-label study to evaluate the safety and feasibility of ATIR201, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), as adjuvant treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation in patients with beta-thalassemia major.

Status: Study is initiated, with regulatory approvals having been received in various countries.

Upcoming Trials

If you are a medical professional and would like information about becoming an investigator for one of our clinical trials, please contact clinicaltrials@kiadis.com