Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
88
Countries
3
Sites
7
B-cell Non-Hodgkins Lymphoma (B-NHL)
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 3 May 2024 → ongoing
- Decision date (initial)
- 2023-08-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502137-26-00
- ClinicalTrials.gov
- NCT05685173
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-cell Non-Hodgkins Lymphoma (B-NHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10029609 | Non-Hodgkin's lymphoma unspecified histology aggressive recurrent | 100000004864 |
| 27.1 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 14 | 3 |
| Netherlands | Temporarily halted | 14 | 2 |
| Spain | Temporarily halted | 14 | 2 |
| Rest of world
United States, United Kingdom
|
— | 46 | — |
Investigational sites
Hopital Saint Louis
Département d’hémato-oncologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Bordeaux
Département d’hémato-clinique et thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Institut Gustave Roussy
Département d’hématologie, 114 Rue Edouard Vaillant, 94800, Villejuif
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 |
|---|---|---|---|---|---|
| France | 2024-07-09 | 2024-10-30 | 2026-04-01 | ||
| Netherlands | 2024-05-03 | 2024-08-09 | 2026-04-01 | ||
| Spain | 2024-05-09 | 2024-05-22 | 2026-04-01 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-127943
- Halt date
- 2026-04-01
- Member states concerned
- Netherlands
- Publication date
- 2026-04-09
- Reason
- Study management related
- Explanation
- Enrollment on the study will be temporary paused until the upcoming protocol amendment 5 is fully approved and implemented at the EU sites since the study Sponsor wants to enroll the next dose level under Global Protocol Amendment 5.
- Follow-up measures
- All participating sites were informed of the upcoming temporary enrollment halt
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-127942
- Halt date
- 2026-04-01
- Member states concerned
- France
- Publication date
- 2026-04-09
- Reason
- Study management related
- Explanation
- Enrollment on the study will be temporary paused until the upcoming protocol amendment 5 is fully approved and implemented at the EU sites since the study Sponsor wants to enroll the next dose level under Global Protocol Amendment 5.
- Follow-up measures
- All participating sites were informed of the upcoming temporary enrollment halt
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-127944
- Halt date
- 2026-04-01
- Member states concerned
- Spain
- Publication date
- 2026-04-09
- Reason
- Study management related
- Explanation
- Enrollment on the study will be temporary paused until the upcoming protocol amendment 5 is fully approved and implemented at the EU sites since the study Sponsor wants to enroll the next dose level under Global Protocol Amendment 5.
- Follow-up measures
- All participating sites were informed of the upcoming temporary enrollment halt
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | Spain | Acceptable with conditions 2023-08-21
|
2023-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-28 | Acceptable with conditions | 2023-10-26 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-11-03 | Acceptable with conditions | 2024-01-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-26 | Spain | Acceptable 2024-03-12
|
2024-03-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-19 | Spain | Acceptable 2025-05-23
|
2025-05-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-22 | Spain | Acceptable 2025-10-06
|
2025-10-06 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-05 | Spain | Acceptable 2025-10-06
|
2026-02-05 |