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

A phase I study to investigate the safety of TEG001 cell suspension for infusion in patients with relapsed/refractory Acute Myeloid Leukemia, high-risk Myelodysplastic Syndrome (IPSS-R score >4,5) or Multiple Myeloma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25189
Enrollment
18
Registered
2017-01-20
Start date
2017-06-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeolid Leukemia (AML) Myelodysplastic syndromes (MDS) Multiple Myeloma (MM) Acute Myeloïde Leukemie (AML) Myelodysplastisch syndroom (MDS) Multipel Myeloom (MM) Ziekte van Kahler

Interventions

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

Sponsors

University Medical Center Utrecht
Lead Sponsor

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

MeasureTime frame
The number of patient with one or more Dose Limiting Toxicities

Secondary

MeasureTime frame
1. number of Adverse Events 2. description of clinical responses 3. levels of TEG001 in peripheral blood

Contacts

Public ContactAnna van Muyden

UMC Utrecht

hemat-research@umcutrecht.nl+31887555878

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)