Safety of TEG001 in patients with r/r AML, high-risk MDS or MM

Background of the study:

In order to further the success of immunotherapies, it is key to improve on the efficacy and applicability of a therapy
and simultaneously diminish the occurrence of severe side effects. TEG001 cell suspension for infusion (TEG001
product) consists of autologous αβT cells, genetically transduced to express a specific γδT cell receptor derived from a
healthy donor. The γδTCR is able to recognise various types of malignant cells. TEG therapy aims to provide a lifelong
protection against malignancies, without affecting healthy tissue. In the future, it is the aim for TEG therapy to serve as
a curative treatment in various haematological and solid malignancies.

Objective of the study:

This study aims to assess the safety of TEG001. Furthermore, the feasibility of TEG001 production with material from
intensively pre-treated patients and TEG001 efficacy parameters will be assessed.

Study design:

This study follows a 3+3 dose escalation design

Study population:

Patients, aged 18-years or over, with a relapsed/refractory Acute Myeloid Leukaemia (AML)/high-risk Myelodysplastic
Syndrome (MDS) (IPSS-R>4.5) or relapsed/refractory Multiple Myeloma (MM) with only standard of care directed
towards support and symptom relief, but no therapeutic treatment options left.

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primary outcome: 28 days post TEG001 infusion

secondary outcomes: 56 days post TEG001 infusion

TEG001 infusion (autologous alfa beta T cells Engineerd to express a defined Gamma delta T cell receptor)