New Phase I/II Trial for Myelodysplastic Syndrome, Acute Myeloid Leukemia, and Multiple Myeloma is Now Underway!

The very first patient in Medigene AG’s clinical trial examining MDG1011 has officially received the treatment. This is the company’s first human clinical trial for this TCR therapy. The trial is examining the safety and efficacy of MDG1011 as a one-time therapy for not one but three different blood cancers- myelodysplastic syndrome (MDS)acute myeloid leukemia (AML), and multiple myeloma (MM). Currently, all three of these conditions have very limited therapeutic options and patient outcomes are typically poor.

If the results from this clinical trial are positive, we could see a new treatment option for these rare disease patients become a reality in the near future.

How MDG1011 Works

MDG1011 is a TCR-T therapy which means that the treatment helps patient’s T cells detect tumors in the body. Once detected, the T cells can begin to kill the cancerous cells. This therapy occurs ex vivo (which means outside the patient’s body). This particular TCR-T treatment uses more tumor antigens than similar CAR-T therapy.

MDG1011 is just one of six TCR-Ts being developed by Medigene AG. This development is possible thanks to their collaboration with Bluebird Bio.

The company’s Phase I/II trial is currently being conducted at three hospitals in Germany. However, up to five more hospitals will begin recruitment within 3-5 months to accelerate the process.

Phase I of the Trial

The Phase I part of this Phase I/II trial for MDG1011 aims to include 12 participants with advanced stage MM, MDS, or AML. All of the enrolled patients must have previously been treated with other therapies, have PRAME expression, and have the HLA-A *02:01 serotype. The study will occur at multiple trial centers and will last a total of 15 months (three months of treatment and 12 months of follow-up).

There will be at least three dose cohorts, each consisting of one MM patient and one MDS or AML patient. There will be a total of 3 patients in each cohort. Each will examine different doses of the T cells, administered according to the patient’s body weight.

The primary endpoints of this part of the trial are safety as well as overall feasibility.

Phase 2 of the Trial

Researchers, of course expect, and hope, for positive results from the Phase I portion of this trial. They aim to move forward in investigation of two of the three cancers in the Phase 2 portion.

40 patients who have PRAME expression and the HLA-A*02:01 and 40 patients who have PRAME expression but do not have the HLA-A*02:01 serotype will be included in this evaluation. For each cancer type, there will be 20 patients treated with MDG1011 and 20 patients in the control group.

This trial will evaluate the safety and efficacy of MDG1011 as its primary endpoints. Efficacy will be evaluated at the three-month mark.

Stay tuned to hear more updates on this trial and the effect this new potential therapy could have for AML, MM, and MDS patients!

You can read more about this new Phase I/II trial here.

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