Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
230
Countries
1
Sites
5
Relapsed/refractory (R/R) B-cell and T-cell lymphomas
Key facts
- Sponsor
- Step Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Oct 2023 → ongoing
- Decision date (initial)
- 2023-05-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502299-21-00
- ClinicalTrials.gov
- NCT05463263
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory (R/R) B-cell and T-cell lymphomas
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10042971 | T-cell lymphoma | 100000004864 |
| 20.0 | PT | 10003899 | B-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Step Pharma
- Sponsor organisation
- Step Pharma
- Address
- 101 Rue De Sevres
- City
- Paris
- Postcode
- 75006
- Country
- France
Scientific contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Public contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 85 | 5 |
| Rest of world
United States, United Kingdom
|
— | 145 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
service de Dermatologie, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Service de dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli-Calmettes
Service d‘hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nantes
Département d‘Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Gustave Roussy
DITEP, 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 | 2023-10-18 | 2023-10-18 |
Application history
21 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-01 | France | Acceptable 2023-05-16
|
2023-05-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-06-01 | France | Acceptable 2023-05-16
|
2023-06-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-09 | France | Acceptable 2023-07-24
|
2023-08-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-12 | France | Acceptable 2023-07-24
|
2023-09-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-06 | France | Acceptable 2023-11-20
|
2023-11-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-01 | France | Acceptable | 2024-02-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-02-29 | France | Acceptable | 2024-02-29 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-03-29 | France | Acceptable | 2024-03-29 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-05-15 | France | Acceptable | 2024-05-15 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-06-13 | France | Acceptable | 2024-06-13 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-14 | France | Acceptable 2024-07-25
|
2024-08-23 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-09-02 | France | Acceptable 2024-07-25
|
2024-09-02 |
| 13 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-27 | France | Acceptable 2025-01-06
|
2025-02-12 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-02-19 | France | Acceptable 2025-01-06
|
2025-02-19 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-02-28 | France | Acceptable 2025-01-06
|
2025-02-28 |
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-04 | France | Acceptable 2025-04-11
|
2025-04-11 |
| 17 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-16 | France | Acceptable 2025-06-26
|
2025-07-11 |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-05 | France | Acceptable 2025-10-07
|
2025-10-10 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-11-07 | France | Acceptable 2025-10-07
|
2025-11-07 |
| 20 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-02 | France | Acceptable 2026-02-23
|
2026-03-12 |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2026-05-12 | France | Acceptable 2026-02-23
|
2026-05-12 |