Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
44
Countries
3
Sites
8
Relapsed/Refractory B-cell Malignancies
Key facts
- Sponsor
- Heidelberg Pharma AG
- 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
- 4 Jun 2025 → 2 Apr 2026
- Decision date (initial)
- 2025-03-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory B-cell Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10084346 | B-cell non-Hodgkin´s lymphoma | 100000004848 |
| 21.1 | LLT | 10068852 | B-cell chronic lymphocytic leukaemia | 10029104 |
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Heidelberg Pharma AG
- Sponsor organisation
- Heidelberg Pharma AG
- Address
- Gregor-Mendel-Strasse 22
- City
- Ladenburg
- Postcode
- 68526
- Country
- Germany
Scientific contact point
- Organisation
- Heidelberg Pharma AG
- Contact name
- Clinical Development
Public contact point
- Organisation
- Heidelberg Pharma AG
- Contact name
- Clinical Development
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 13 | 4 |
| Romania | Ended | 8 | 2 |
| Spain | Ended | 7 | 2 |
| Rest of world
Moldova, Republic of, Israel
|
— | 16 | — |
Investigational sites
Aidport Sp. z o.o.
NA, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Pratia S.A.
Site name:Pratia MCM Kraków, Pana Tadeusza 2, 30-727 Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
Pratia Hematologia Sp. z o.o.
Site name:Pratia Onkologia Katowice, ul. Kosciuszki 92, 40-519 Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Mtz Clinical Research Powered By Pratia
NA, Ul. Gładka 22, 02-172, Warsaw
Arensia Clinics S.R.L.
Research Facility, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Radioterapie I - Oncologie, Strada Republicii 34-36, 400015, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Poland | 2025-06-04 | 2025-08-19 | 2025-09-01 | ||
| Romania | 2025-06-04 | 2025-06-16 | 2025-09-01 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-96537
- Halt date
- 2025-09-01
- Member states concerned
- Poland
- Publication date
- 2025-09-04
- Reason
- Sponsor decision
- Explanation
- The enrollment of the above-mentioned study is being halted. The temporary halt is not related to reasons of patients’ safety or product quality. The decision is driven by a strategic business review of recourse allocation and funding considerations. Treatment, follow-up and safety of enrolled patients will continue as per protocol requirements and ethical standards.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-96539
- Halt date
- 2025-09-01
- Member states concerned
- Romania
- Publication date
- 2025-09-04
- Reason
- Sponsor decision
- Explanation
- The enrollment of the above-mentioned study is being halted. The temporary halt is not related to reasons of patients’ safety or product quality. The decision is driven by a strategic business review of recourse allocation and funding considerations. Treatment, follow-up and safety of enrolled patients will continue as per protocol requirements and ethical standards.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-12 | Spain | Acceptable 2025-03-07
|
2025-03-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-28 | Spain | Acceptable 2025-07-11
|
2025-07-15 |