No registrations found.
ID
Source
Brief title
Health condition
Acute Myeolid Leukemia (AML)
Myelodysplastic syndromes (MDS)
Multiple Myeloma (MM)
Acute Myeloïde Leukemie (AML)
Myelodysplastisch syndroom (MDS)
Multipel Myeloom (MM)
Ziekte van Kahler
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of patient with one or more Dose Limiting Toxicities
Secondary outcome
1. number of Adverse Events
2. description of clinical responses
3. levels of TEG001 in peripheral blood
Background summary
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.
Study objective
-
Study design
primary outcome: 28 days post TEG001 infusion
secondary outcomes: 56 days post TEG001 infusion
Intervention
TEG001 infusion (autologous alfa beta T cells Engineerd to express a defined Gamma delta T cell receptor)
Anna van Muyden
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31887555878
hemat-research@umcutrecht.nl
Anna van Muyden
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31887555878
hemat-research@umcutrecht.nl
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6357 |
| NTR-old | NTR6541 |
| CCMO | NL58686.000.16 |
| OMON | NL-OMON47707 |