Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
8
Countries
1
Sites
3
Relapsed Acute Leukemia
To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells. To evaluate the incidence of aGVHD and cGVHD. To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device.
Key facts
- Sponsor
- Nosokomeio Paidon I Agia Sofia
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 23 Nov 2022 → ongoing
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516091-15-00
- EudraCT number
- 2021-003445-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells.
To evaluate the incidence of aGVHD and cGVHD.
To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device.
Secondary objectives 1
- To evaluate the duration of in vivo persistence of adoptively transferred DDCAR-CD19 cells. To evaluate B-cell aplasia.
Conditions and MedDRA coding
Relapsed Acute Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10063620 | Acute lymphocytic leukaemia recurrent | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Individuals between 6 months and 39 years of age who have recurrent or persistent CD19 (+) acute leukemia after allogeneic HSCT or following autologous CAR-T cell therapy - ≥5 X 10-4 CD19+ blast cells in bone marrow as determined per flow cytometry, or isolated extramedullary relapse. - No evidence of ≥ grade II aGVHD or chronic GVHD while off of systemic immunosuppressive therapy for at least 4 weeks. - Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50 - Availability of the initial stem cell donor.
Exclusion criteria 1
- Active severe infection Active aGVHD Grade ≥II <30% expression of CD19 on the leukemic population Presence of a CD19-negative leukemic subclone Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids Eligible for therapy with recipient-derived CAR-T cells
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion
Secondary endpoints 1
- Duration of DDCART cell detection in patients' blood Duration of B-cell aplasia Correlation of DDCART cell and B-cells detection with disease relapse
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11665554 · Product
- Active substance
- DDCARTCD19
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5000000 Other
- Max total dose
- 10000000 Other
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- NOSOKOMEIO PAIDON I AGIA SOFIA
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nosokomeio Paidon I Agia Sofia
- Sponsor organisation
- Nosokomeio Paidon I Agia Sofia
- Address
- Thivon, Papadiamantopoulou Papadiamantopoulou
- City
- Athens
- Postcode
- 115 27
- Country
- Greece
Scientific contact point
- Organisation
- Nosokomeio Paidon I Agia Sofia
- Contact name
- Evgenios Goussetis
Public contact point
- Organisation
- Nosokomeio Paidon I Agia Sofia
- Contact name
- Evgenios Goussetis
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Coronis Research S.A. ORG-100028085
|
Chalandri, Greece | On site monitoring, Code 10, Code 11, Other, Code 5, Data management, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruiting | 8 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Nosokomeio Paidon I Agia Sofia
Center for Cell and Gene Therapy, Children's Oncology Unit - Marianna V. Vardilogianni "ELPIDA", Thivon, Papadiamantopoulou, Athens
Evaggelismos Hospital
Hematology Clinic - Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic, Rimini Street 1, 124 62, Athens
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 |
|---|---|---|---|---|---|
| Greece | 2022-11-23 | 2023-03-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ELPIDA-ALLOCART-01_Protocol_v1_GR | 1 |
| Recruitment arrangements (for publication) | K1_ELPIDA-ALLOCART-01_Recruitment Arrangement Statement | 1 |
| Subject information and informed consent form (for publication) | L1_ELPIDA-ALLOCART-1_ICF_10-13years_v2_GR | 2 |
| Subject information and informed consent form (for publication) | L1_ELPIDA-ALLOCART-1_ICF_14-17years_v2_GR | 2 |
| Subject information and informed consent form (for publication) | L1_ELPIDA-ALLOCART-1_ICF_Adults_v2_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ELPIDA-ALLOCART-1_ICF_Parents_v2_GR_Redacted | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Greece | Acceptable 2024-11-19
|
2024-11-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-26 | Greece | Acceptable 2024-11-19
|
2025-06-26 |