Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
116
Countries
4
Sites
9
Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Key facts
- Sponsor
- Dren Bio 01 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
- 8 Aug 2024 → ongoing
- Decision date (initial)
- 2023-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503550-13-00
- ClinicalTrials.gov
- NCT05475925
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10029430 | NK-cell leukemia | 10029104 |
| 21.1 | LLT | 10065862 | T-cell large granular lymphocytic leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dren Bio 01 Inc.
- Sponsor organisation
- Dren Bio 01 Inc.
- Address
- 835 Industrial Road Fl 4
- City
- San Carlos
- Postcode
- 94070-3328
- Country
- United States
Scientific contact point
- Organisation
- Dren Bio 01 Inc.
- Contact name
- Alissa Keegan MD, PhD
Public contact point
- Organisation
- Dren Bio 01 Inc.
- Contact name
- Shalini Gidwani
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 13 | 3 |
| Germany | Ongoing, recruiting | 13 | 3 |
| Italy | Ongoing, recruiting | 13 | 1 |
| Spain | Ongoing, recruiting | 12 | 2 |
| Rest of world
United States, Australia
|
— | 65 | — |
Investigational sites
Hospices Civils De Lyon
Service Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Claudius Regaud
Hematology department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Rennes
Service de d’Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
University Hospital Cologne AöR
Department I of Internal Medicine, Kerpener Strasse 62, Lindenthal, Cologne
Charite Universitaetsmedizin Berlin KöR
Dermatologie, Venerologie und allergologie, Chariteplatz 1, Mitte, Berlin
Universitaet Leipzig
Medical department for Hematology, cell Therapie and Hemostaseology, Johannisallee 30, Zentrum-Suedost, Leipzig
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
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 | 2024-08-08 | 2025-10-06 | |||
| Germany | 2024-12-19 | 2026-01-21 | |||
| Italy | 2024-10-22 | 2024-10-22 | |||
| Spain | 2024-09-13 | 2024-09-13 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-17 | Spain | Acceptable with conditions 2023-07-03
|
2023-07-03 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-10-24 | 2024-02-02 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-11-09 | 2024-02-13 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Spain | Acceptable 2024-05-22
|
2024-05-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-09 | Spain | Acceptable 2024-05-22
|
2024-07-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-11 | Acceptable | 2024-08-23 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-11 | Acceptable | 2024-08-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-11 | Spain | Acceptable | 2024-08-02 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-08 | Acceptable | 2024-11-15 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-10-08 | Acceptable | 2024-10-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-08 | Spain | Acceptable | 2024-11-04 |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-10-08 | Acceptable | 2024-11-21 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-14 | Spain | Acceptable 2025-08-22
|
2025-08-22 |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-10 | Spain | Acceptable 2025-11-05
|
2025-11-05 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-11-17 | Spain | Acceptable 2025-11-05
|
2025-11-17 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-11-26 | Spain | Acceptable 2025-11-05
|
2025-11-26 |
| 17 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-01 | Spain | Acceptable 2026-02-16
|
2026-02-16 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-02-26 | Spain | Acceptable 2026-02-16
|
2026-02-26 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-04-29 | Spain | Acceptable 2026-02-16
|
2026-04-29 |