Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
298
Countries
1
Sites
1
B-cell non-Hodgkin lymphoma (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
- 31 Aug 2016 → 22 Aug 2025
- Decision date (initial)
- 2024-07-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514938-20-00
- EudraCT number
- 2015-004491-30
- ClinicalTrials.gov
- NCT02290951
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-cell non-Hodgkin lymphoma (NHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10025311 | Lymphoma (non-Hodgkin's) | 10029104 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
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
- Head EU Regulatory Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Head EU Regulatory Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 65 | 1 |
| Rest of world
United States, Israel, United Kingdom
|
— | 233 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2016-08-31 | 2025-08-21 | 2016-08-31 | 2023-03-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 49 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | m5352-r1979-hm-1333-ptf-1422-34 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-120dsu-figures-batch1 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-120dsu-figures-batch2 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-120dsu-tables-batch1 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-120dsu-tables-batch2 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-14115-14234-tables | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-1421-q151-q152-tables | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-14211-14234-figures | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-cp-report | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-csr-body | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-csr-synopsis | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpo-1-20-60mg | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpo-1-20-60mg-ind | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpo-1421115 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpo-1421116 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpr-07-4-20-160mg | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpr-07-4-20-160mg-ind | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpr-1421115 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-edtpr-1421116 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-figure-q15 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-narratives | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-prot-amend-16 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-prot-amend-16-us-1 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptf-14211-118 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptf-142115-16 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptf-142119 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptf-14341-6 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptf-14342-4 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14111-44 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14211-43 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143121-41 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143125-14 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143131-39 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143211-261 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143311-13 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143321-23 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143331-33 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-143341-353 | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341fl | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sa | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sda | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sdnta | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sdta | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sdtp | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sga | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-ptt-14341sxa | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-question-outputs-final | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-sample-crf | 1 |
| Clinical study report (for publication) | m5352-r1979-hm-1333-s-sap | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Germany | Acceptable 2024-06-27
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-30 | Germany | Acceptable 2025-08-29
|
2025-09-01 |