Acute Myeolid Leukemia (AML) Myelodysplastic syndromes (MDS) Multiple Myeloma (MM) Acute Myeloïde Leukemie (AML) Myelodysplastisch syndroom (MDS) Multipel Myeloom (MM) Ziekte van Kahler
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age ¡Ý 18-years - Relapsed/refractory Acute Myeloid Leukemia, high-risk Myelodysplastic Syndrome (IPSS-R score >4,5) or Multiple Myeloma, for which no remaining standard of care or approved treatment options are available
Exclusion criteria
Exclusion criteria: - In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures - Central Nervous System involvement of the haematological malignancy - Other concurrent malignancy requiring treatment - Treatment with antitumor therapy (conventional or experimental) < 28-days before start of the study treatment - Active endogenous retrovirus - Active GVHD and/or systemic immune suppression; < 28 days before start of the study treatment - Uncontrolled infections - Inadequate renal, hepatic, pulmonary and cardiac function - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patient with one or more Dose Limiting Toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. number of Adverse Events 2. description of clinical responses 3. levels of TEG001 in peripheral blood | — |
Contacts
UMC Utrecht