Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
60
Countries
2
Sites
8
Relapsed and Refractory Multiple Myeloma
Key facts
- Sponsor
- K36 Therapeutics 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
- 26 Jul 2023 → ongoing
- Decision date (initial)
- 2023-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500801-41-00
- ClinicalTrials.gov
- NCT05651932
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
K36 Therapeutics Inc.
- Sponsor organisation
- K36 Therapeutics Inc.
- Address
- 1 Main Street 13
- City
- Cambridge
- Postcode
- 02142-1517
- Country
- United States
Scientific contact point
- Organisation
- K36 Therapeutics Inc.
- Contact name
- Sanjana Miskin
Public contact point
- Organisation
- K36 Therapeutics Inc.
- Contact name
- Soo Bang
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 12 | 4 |
| Spain | Ongoing, recruiting | 12 | 4 |
| Rest of world
United States, Canada
|
— | 36 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Poitiers
Hematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonovski, 59037, Lille Cedex
Hospital Clinic De Barcelona
Servicio de Hematología, Calle Villarroel 170, 08036, Barcelona
University Clinic Of Navarra
Hematology, Avenida De Pio XII 36, 31008, Pamplona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario 12 De Octubre
Servicio de Hematología, Avenida De Cordoba Sn, 28041, Madrid
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 | 2023-09-12 | 2023-09-13 | |||
| Spain | 2023-07-26 | 2023-11-09 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-17 | France | Acceptable with conditions 2023-03-06
|
2023-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-15 | France | 2023-04-24 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-30 | France | 2023-05-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-11 | Acceptable with conditions | 2023-09-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-11-10 | Acceptable with conditions | 2023-11-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-05 | France | Acceptable with conditions | 2024-02-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-26 | France | Acceptable with conditions | 2024-04-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-23 | France | 2024-04-23 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-04-23 | France | 2024-04-23 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-01-28 | France | Acceptable 2025-04-29
|
2025-04-29 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-05-14 | Acceptable | 2025-06-02 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-14 | France | Acceptable | 2025-06-25 |