Clinical trial • Not applicable • Haematology|Immunology|Other

LISOCABTAGENE MARALEUCEL for Hematologic disease|Immune effector cell-associated neurotoxicity syndrome (ICANS)|CAR T-cell therapy

Not applicable trial of LISOCABTAGENE MARALEUCEL for Hematologic disease|Immune effector cell-associated neurotoxicity syndrome (ICANS)|CAR T-cell therapy.

Overview

Trial Therapeutic Area
Haematology|Immunology|Other
Trial Disease
Hematologic disease|Immune effector cell-associated neurotoxicity syndrome (ICANS)|CAR T-cell therapy
Trial Stage
Not applicable
Drug Modality
Cell therapy|Diagnostic agent

Key dates

Initial CTIS Submission Date
01-07-2024
First CTIS Authorization Date
04-09-2024

Trial design

open-label Not applicable trial across 5 sites in France.

Open Label
Yes
Target Sample Size
60

Eligibility

Recruits 60 Patients deprived of liberty or under legal protection (tutelle, curatelle, sauvegarde de justice, habilitation familiale) are explicitly excluded. Patients unable to understand informed consent are excluded. Inclusion requires the adult patient to have received information and to have co-signed an informed consent form with the investigator. Only adults (>18 years) are eligible; no assent process for minors is described and is not applicable..

Pregnancy Exclusion
Pregnant or breast-feeding woman
Vulnerable Population
Patients deprived of liberty or under legal protection (tutelle, curatelle, sauvegarde de justice, habilitation familiale) are explicitly excluded. Patients unable to understand informed consent are excluded. Inclusion requires the adult patient to have received information and to have co-signed an informed consent form with the investigator. Only adults (>18 years) are eligible; no assent process for minors is described and is not applicable.

Inclusion criteria

  • {"criterion_text":"- Patient over 18 years old"}
  • {"criterion_text":"- Patients for whom CAR-T treatment of their disease is indicated"}
  • {"criterion_text":"- Patient affiliated to or entitled under a social security scheme"}
  • {"criterion_text":"- Patient has received informed consent to participate in the study and has co-signed a consent form with the investigator."}

Exclusion criteria

  • {"criterion_text":"- Pregnant or breast-feeding woman"}
  • {"criterion_text":"- Patient unable to understand informed consent"}
  • {"criterion_text":"- Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation)."}
  • {"criterion_text":"- Contraindication to MRI"}
  • {"criterion_text":"- Contraindication to contrast product"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Quantification and characterization endothelial EVs.","definition_or_measurement_approach":"Quantification (in concentration EVs/mL) and characterization (size and immunophenotyping of EVs) of endothelial EVs over time before and after CAR-T cell treatment according to ICANS grade."}

Secondary endpoints

  • {"endpoint_text":"- Quantification and characterization of other EVs subtypes as a function of time before and after treatment with CAR-T cells according to ICANS grade.","definition_or_measurement_approach":"Quantification and characterization of other EV subtypes over time before and after CAR-T treatment according to ICANS grade."}
  • {"endpoint_text":"- Quantification and characterization of EVs according to the presence of an ICANS versus no ICANS.","definition_or_measurement_approach":"Comparison of EV quantification and characterization between patients with ICANS and those without ICANS."}
  • {"endpoint_text":"- Quantification and characterization of EVs according to levels of cytokines.","definition_or_measurement_approach":"Assessment of EVs in relation to plasma cytokine levels."}
  • {"endpoint_text":"- Quantification and structural and molecular characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.","definition_or_measurement_approach":"Quantification and structural/molecular characterization of EVs in CSF samples when available after CAR-T treatment."}
  • {"endpoint_text":"- Characterization of the association of subpopulations of EVs according to clinical neurological impairment and the presence or absence of a sleep apnea syndrome.","definition_or_measurement_approach":"Analysis of EV subpopulation associations with clinical neurological impairment and presence/absence of sleep apnea syndrome."}
  • {"endpoint_text":"- Characterization of the association of EVS subpopulations according to cognitive assessment and MRI before lymphodepleting chemotherapy and at the time of ICANS.","definition_or_measurement_approach":"Correlation of EV subpopulations with cognitive assessment results and MRI findings before lymphodepleting chemotherapy and at ICANS occurrence."}
  • {"endpoint_text":"- Description of involvement on MRI before lymphodepleting chemotherapy and at the time of ICANS.","definition_or_measurement_approach":"Descriptive assessment of MRI abnormalities before lymphodepleting chemotherapy and at the time of ICANS."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
38
Consent Approach
Adult patients provide informed consent and must co-sign the consent form with the investigator. A subject information sheet and informed consent form for adults is documented (L1_SIS and ICF_adult). Patients unable to understand informed consent are excluded. No assent for minors is described.

Geography

Total Number Of Sites
5
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
17-04-2025
Processing Time Days
231
Number Of Sites
5
Number Of Participants
60

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical hematology
Contact Person Name
Manon SAPET
Contact Person Email
manon.sapet@chu-st-etienne.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical hematology
Contact Person Name
Jérôme CORNILLON
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical hematology
Contact Person Name
Emanuelle TAVERNIER
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical hematology
Contact Person Name
Emilie CHALAYER
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical hematology
Contact Person Name
Ludovic FOUILLET

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Saint Etienne
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Breyanzi 1.1-70 × 106 cells/mL / 1.1-70 × 106 cells/mL dispersion for infusion
Active Substance
LISOCABTAGENE MARALEUCEL
Modality
Cell therapy
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
Active Substance
AXICABTAGENE CILOLEUCEL
Modality
Cell therapy
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
Abecma 260 - 500 x 10^6 cells dispersion for infusion
Active Substance
IDECABTAGENE VICLEUCEL
Modality
Cell therapy
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
GADOVIST 1,0 mmol/mL, solution injectable
Active Substance
GADOBUTROL
Modality
Diagnostic agent
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
Intravenous administration
Authorisation Status
Authorised (marketing authorisation present)
Starting Dose
0.1 mmol/kg
Maximum Dose
0.1 mmol/kg
Investigational Product Name
Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
Active Substance
TISAGENLECLEUCEL
Modality
Cell therapy
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
Tecartus 0.4 - 2 x 10e8 cells dispersion for infusion
Active Substance
BREXUCABTAGENE AUTOLEUCEL
Modality
Cell therapy
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)

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