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van CCT (UK)

van CCT (UK)

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

- candidate number26514
- NTR NumberNTR6541
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2017
- Secondary IDsNL58686.000.16 / CCMO17.0304 Toetsingonline / CCMO
- Public TitleSafety of TEG001 in patients with r/r AML, high-risk MDS or MM
- Scientific TitleA 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
- hypothesis
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Kahler's disease, Multiple Myeloma (MM), Myelodysplastic syndrome (MDS)
- Inclusion criteria- Age 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-jan-2025
- Target number of participants18
- InterventionsTEG001 infusion (autologous alfa beta T cells Engineerd to express a defined Gamma delta T cell receptor)
- Primary outcomeThe number of patient with one or more Dose Limiting Toxicities
- Secondary outcome1. number of Adverse Events
2. description of clinical responses
3. levels of TEG001 in peripheral blood
- Timepointsprimary outcome: 28 days post TEG001 infusion
secondary outcomes: 56 days post TEG001 infusion
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw, KWF Kankerbestrijding, Gadeta B.V.
- Publications
- Brief summaryBackground 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.
- Main changes (audit trail)
- RECORD20-jan-2017 - 5-aug-2017

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