MDG1021, which targets the antigen HA-1, is Medigene's second proprietary T cell receptor-modified T cell (TCR-T) immunotherapy candidate to enter clinical development. The Phase I study of MDG1021 will enroll patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation (allo-HSCT), an area with high unmet medical need.
Medigene in-licensed the HA‑1 TCR from the Leiden University Medical Center (LUMC), the Netherlands, at the end of 2018. The TCR was developed by LUMC and positively evaluated for preliminary safety and tolerability in a first Phase I clinical trial involving five patients. In May 2019, Medigene entered into a Clinical Trial Agreement with LUMC to conduct a further Phase I clinical trial of MDG1021. In June 2019, Medigene received the clinical trial approval from the Dutch regulatory authority.
|Clinical trial phase|
Phase I with a dose escalation part of at least 9 patients and a dose expansion part of 20 additional patients.
Safety and feasibility of MDG1021 immunotherapy
Clinicaltrials.gov: HA-1H TCR T Cell for Relapsed/Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplantation
Which patients were treated?
Patients suffering from blood cancers are treated with chemotherapy. Where possible this chemotherapy is followed by an allo-HSCT as the preferred treatment option where the donor stem cells re-establish a blood forming system in the patient. However, patients who suffer from a relapse of their cancers after allo-HSCT currently have few treatment options.
MDG1021 is a TCR-T immunotherapy targeting a specific, immunogenic form of the antigen HA-1. HA-1 is exclusively expressed on cells of the hematopoietic system. If the patient's blood-cells, and thus lymphoma or leukemic cells, carry the immunogenic version of the HA-1 antigen on their surface and the donor stem cells do not, MDG1021 TCR-T cells could eradicate the patient's cancer cells and allow the donor stem cells to repopulate the patient's blood forming system.
Where is the clinical trial being conducted?
Leiden University Medical Center (LUMC), the Netherlands