Clinical trial • Phase IV • Immunology|Oncology
Autologous enriched T cells retrovirally transduced to express two chimeric antigen receptors targeting CD19 and CD22 for Secondary malignancy following CAR T-cell therapy|Acute lymphoblastic leukemia|Non-Hodgkin's lymphoma|Systemic lupus erythematosus
Phase IV trial of Autologous enriched T cells retrovirally transduced to express two chimeric antigen receptors targeting CD19 and CD22 for Secondary mali…
Overview
- Trial Therapeutic Area
- Immunology|Oncology
- Trial Disease
- Secondary malignancy following CAR T-cell therapy|Acute lymphoblastic leukemia|Non-Hodgkin's lymphoma|Systemic lupus erythematosus
- Trial Stage
- Phase IV
- Drug Modality
- Cell therapy|Monoclonal antibody
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 13-03-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
open-label, none/not specified-controlled Phase IV trial across 4 sites in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 90
- Trial Duration For Participant
- 5475
Eligibility
Recruits 90 paediatric patients.
- Vulnerable Population
- Vulnerable populations included: children/adolescents. Study materials include child assent form, age-specific subject information and informed consent forms for 8 to 11 years and 12 to 17 years, Parent/Guardian ICFs and adolescent-to-adult re-consent letters; consent is obtained from the participant or from parent/guardian as applicable, with child assent for minors.
Inclusion criteria
- {"criterion_text":"- Patients must have received an AUTO CAR T cell therapy on a previous treatment study.\n- Patients must have provided informed consent for long-term follow-up study prior to participation.\n- Patients must be able to comply with the study requirements."}
Exclusion criteria
- {"criterion_text":"- There are no exclusion criteria for this study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of serious adverse events related to AUTO CAR T cell therapy","definition_or_measurement_approach":"Measured as the incidence (occurrence) of serious adverse events judged related to AUTO CAR T cell therapy over follow-up."}
- {"endpoint_text":"- New malignancies","definition_or_measurement_approach":"Identification and recording of any new malignancies occurring during follow-up."}
- {"endpoint_text":"- Other designated adverse events of special interest related to AUTO CAR T cell therapy","definition_or_measurement_approach":"Recording and monitoring of predefined adverse events of special interest related to AUTO CAR T cell therapy."}
Secondary endpoints
- {"endpoint_text":"- Overall survival for up to 15 years after the first AUTO CAR T cell therapy infusion","definition_or_measurement_approach":"Overall survival measured up to 15 years from the first AUTO CAR T infusion."}
- {"endpoint_text":"- Duration of supportive care","definition_or_measurement_approach":"Length of time patients require supportive care interventions (no further detail provided)."}
- {"endpoint_text":"- Duration of response, progression-free survival","definition_or_measurement_approach":"Duration of clinical response and progression-free survival as recorded during follow-up."}
- {"endpoint_text":"- Proportion of patients with detectable vector copy number in peripheral blood for up to 15 years from first AUTO CAR T cell therapy infusion","definition_or_measurement_approach":"Proportion of patients with detectable vector copy number in peripheral blood, assessed over a 15-year period from first infusion."}
- {"endpoint_text":"- Confirm / monitor for absence of detectable RCR/RCL for up to 15 years from first AUTO CAR T cell therapy infusion","definition_or_measurement_approach":"Periodic testing to confirm absence (or detect presence) of replication competent retrovirus (RCR) or lentivirus (RCL) up to 15 years."}
- {"endpoint_text":"- In case of new malignancy: Insertion site analysis to determine insertional mutagenesis as potential cause/contributor","definition_or_measurement_approach":"If a new malignancy arises, perform insertion site analysis to assess whether insertional mutagenesis may be causative or contributory."}
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 181
- Consent Approach
- Informed consent obtained prior to participation; age-specific information and consent/assent documents available (Parent/Guardian ICF, child assent form, SIS and ICF for 8-11 years and 12-17 years, adolescent-to-adult re-consent letters). There are additional ICFs for patient becoming pregnant and pregnant partner. Materials and translations include English and Spanish protocol synopses; consent is provided by participants or parent/guardian as applicable, with assent for minors.
Methods
- Patients may be enrolled following their AUTO CAR T cell therapy treatment (clinic-based enrolment of previously treated AUTO CAR T cell therapy patients).
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 90
Spain
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 26-06-2025
- Processing Time Days
- 350
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Paediatric Haemato-Oncology
- Contact Person Name
- Gloria Lacoboni
- Contact Person Email
- giacoboni@vhio.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Contact Person Name
- Manuel Guerreiro
- Contact Person Email
- Manuel_direito@iislafe.es
- Site Name
- Hospital Universitari Vall d'Hebron
- Department Name
- Haematology
- Contact Person Name
- Josefina Cortes
- Contact Person Email
- fina.cortes@vhir.org
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Paediatric Haemato-Oncology
- Contact Person Name
- Alba Rubio
- Contact Person Email
- alba.rubio@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Autolus Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- AUTO1
- Active Substance
- Autologous enriched T cells retrovirally transduced to express two chimeric antigen receptors targeting CD19 and CD22
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Maximum Dose
- 100 U/g unit(s)/gram
- Investigational Product Name
- AUTO4
- Active Substance
- AUTO4
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 1
- Maximum Dose
- 25 U/g unit(s)/gram
- Investigational Product Name
- MabThera 100 mg concentrate for solution for infusion
- Active Substance
- Rituximab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 375 mg/m2
- Investigational Product Name
- MabThera 500 mg concentrate for solution for infusion
- Active Substance
- Rituximab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 375 mg/m2
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