Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
18
Countries
1
Sites
1
Acute Myeloid Leukemia (AML)
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Oct 2024 → 20 Jan 2026
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517381-42-00
- EudraCT number
- 2016-003164-39
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia (AML)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088026 | Myelodysplastic syndrome progression to higher risk | 100000004848 |
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Ingrid Spaan
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Ingrid Spaan
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-10-14 | 2024-10-14 | 2025-11-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-106543
- Halt date
- 2025-11-06
- Member states concerned
- Netherlands
- Publication date
- 2025-11-14
- Reason
- Investigator/Site related, Feasibility (recruitment issues etc.)
- Explanation
- The clinical trial drug product TEG001 cell suspension for infusion, is manufactured at the Cell Therapy Facility (CTF) of UMC Utrecht at Heidelberglaan 100, 3584 CX Utrecht the Netherlands. During the mandatory annual (re)classification of this site, it was determined that the facility does not meet the required GMP quality standards necessary for ATMP production. The mandatory requirements have not been achieved, even after modifications were made to the infrastructure in an effort to resolve the issue. As a result of non-compliance with these mandatory GMP standards, the facility cannot currently be released for production of ATMP, including the clinical trial drug product TEG001 cell suspension for infusion.
- Follow-up measures
- The CTF user council is currently in close consultation with all relevant stakeholders and the institution board of directors to assess the available options for restarting production, either at the existing CTF facility or at the new CTF production site at UMC Utrecht, which is currently validated for use. At the same time, we are in discussion with KWF, the funding partner of this study, to determine possible solutions.
All subjects that were included in this clinical trial have completed study participation, including long term follow-up. During the Temporary halt of this study, the principal investigator, study team, and independent expert will remain available for any questions previously included participants may have, or to report any significant events as per study protocol. The UMCU will remain available to fulfill all sponsor requirement for this clinical trial.
In the event that ATMP production can be resumed following the GMP quality standards, a comprehensive action plan will be implemented that will include the review, and if necessary amendment, of all study documents for this clinical trial. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Netherlands | Acceptable with conditions 2024-10-14
|
2024-10-14 |