Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
5
hematology
Describe the characteristics of endothelial EVs and their temporal evolution before and after treatment with CAR-T cells according to ICANS grade.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 2 Jul 2025 → ongoing
- Decision date (initial)
- 2024-09-10
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fonds d’Action CHU Loire · Université Jean Monnet · Ligue contre le cancer · AIRE
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Describe the characteristics of endothelial EVs and their temporal evolution before and after treatment with CAR-T cells according to ICANS grade.
Secondary objectives 7
- Describe the characteristics of EVs and their temporal evolution before and after CAR-T cell treatment as a whole and by subtype according to ICANS grade (grade 0 to 4).
- Describe the differences in the profiles and temporal expression levels of EVs between patients with ICANS versus no ICANS.
- Describe the differences in the profiles and temporal expression levels of EVs in relation to the profile of cytokines secreted during CAR-T treatment and the occurrence or non-occurrence of ICANS.
- Describe the characteristics of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
- Describe the association of EVs subpopulations according to clinical neurological impairment and the presence or absence of sleep apnea syndrome.
- Describe the association of EVs subpopulations according to cognitive assessment and MRI.
- Describe MRI anomalies.
Conditions and MedDRA coding
hematology
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10081306 | CAR T-cell therapy | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment cellular therapy using CAR-T cells
|
Not Applicable | None | cellular therapy using CAR-T cells: CAR-T cell therapy involves the use of several products which are used for this research according to standard of care: - YESCARTA (axicabtagene ciloleucel) - TECARTUS (Brexucabtagene autoleucel) - KYMRIAH (Tisagenlecleucel) - BREYANZI (Lisocabtagene maraleucel) - ABECMA (Idecabtagene vicleucel) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patient over 18 years old
- Patients for whom CAR-T treatment of their disease is indicated
- Patient affiliated to or entitled under a social security scheme
- Patient has received informed consent to participate in the study and has co-signed a consent form with the investigator.
Exclusion criteria 5
- Pregnant or breast-feeding woman
- Patient unable to understand informed consent
- Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
- Contraindication to MRI
- Contraindication to contrast product
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Quantification and characterization endothelial EVs.
Secondary endpoints 7
- Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade.
- Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS.
- Quantification and characterization of EVs according to levels of cytokines.
- Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.
- Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome.
- Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS.
- Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Tecartus 0.4 - 2 x 10e8 cells dispersion for infusion
PRD8604659 · Product
- Active substance
- Brexucabtagene Autoleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL06 — -
- Marketing authorisation
- EU/1/20/1492/001
- MA holder
- KITE PHARMA EU B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
PRD6563420 · Product
- Active substance
- Axicabtagene Ciloleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX70 — -
- Marketing authorisation
- EU/1/18/1299/001
- MA holder
- KITE PHARMA EU B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Breyanzi 1.1-70 × 106 cells/mL / 1.1-70 × 106 cells/mL dispersion for infusion
PRD9615667 · Product
- Active substance
- Lisocabtagene Maraleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- NOT ASS — -
- Marketing authorisation
- EU/1/22/1631/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abecma 260 - 500 x 10^6 cells dispersion for infusion
PRD9253941 · Product
- Active substance
- Idecabtagene Vicleucel
- Substance synonyms
- BB2121
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL07 — -
- Marketing authorisation
- EU/1/21/1539/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
PRD6577962 · Product
- Active substance
- Tisagenlecleucel
- Substance synonyms
- Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19, TISAGENLECLEUCEL-T, CTL019
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL04 — -
- Marketing authorisation
- EU/1/18/1297/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
GADOVIST 1,0 mmol/mL, solution injectable
PRD1854971 · Product
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA09 — GADOBUTROL
- Marketing authorisation
- 34009 279 081 6 3
- MA holder
- BAYER HEALTHCARE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- Avenue Albert Raimond
- City
- Saint Priest En Jarez
- Postcode
- 42270
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Project manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Project manager
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Saint Etienne
Clinical hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Saint Etienne
Clinical hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Saint Etienne
Clinical hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Saint Etienne
Clinical hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Saint Etienne
Clinical hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
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 | 2025-07-02 | 2025-07-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515328-35-00 | 1.1 |
| Protocol (for publication) | D1_Protocol_2024-515328-35-00_TC | 1.1 |
| Protocol (for publication) | D4_Patient facing document | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adult | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adult_TC | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ABECMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BREYANZI | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_KYMRIATH | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_TECARTUS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_YESCARTA | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515328-35-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515328-35-00_TC | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-01 | France | Acceptable 2024-09-04
|
2024-09-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-17 | France | Acceptable 2024-09-04
|
2025-04-17 |