AUTOLOGOUS T-CELLS EX VIVO MODIFIED WITH A LENTIVIRAL VECTOR ENCODING A CHIMERIC ANTIGEN RECEPTOR SPECIFIC FOR CD1A for T-cell acute lymphoblastic leukemia|T-cell lymphoblastic lymphoma

Inclusion criteria

• {"criterion_text":"- Patients previously treated with at least one fraction of OC-1 cell investigational product"}
• {"criterion_text":"- Patient or patient’s legal representative has provided signed and dated informed consent."}
• {"criterion_text":"- Patient is able to comply with the study requirements."}

Exclusion criteria

• {"criterion_text":"- None. All patients who have received prior treatment with OC-1 cell investigational product are eligible for this long-term follow up (LTFU) study."}

Primary endpoints

• {"endpoint_text":"- Number of adverse events grade III-IV, related or possibly related, using Common Toxicity Criteria for Adverse Events (CTCAE) version 5","definition_or_measurement_approach":"Assessment of adverse events grade III-IV using CTCAE version 5; counting events related or possibly related to product."}
• {"endpoint_text":"- Proportion of patients with: - New malignancies. - Incidence/exacerbation of pre-existing neurologic disorder. - New incidence or exacerbation of a prior rheumatologic or other ATMP-CLINICAL TRIAL PROTOCOL OC-01-23002 EU CT Number: 2024-516617-20-00 Page 6 de 39 Protocol Version 1, 4 november 2024 autoimmune disorder. - New incidence of a hematologic disorder. - New incidence of infection (potentially product-related)- - New incidence of skin disorder","definition_or_measurement_approach":"Measured as the proportion of patients experiencing each listed new or exacerbated condition (new malignancies; neurologic disorder incidence/exacerbation; rheumatologic/autoimmune disorder incidence/exacerbation; hematologic disorder; infection potentially product-related; skin disorder)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival following OC-1 cell therapy infusion","definition_or_measurement_approach":"Measured as overall survival (time from OC-1 infusion to death from any cause)."}
• {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"Measured as progression-free survival (time from infusion to disease progression or death); exact protocol definition not provided in source."}
• {"endpoint_text":"- Progression-free survival in patients who did not received HSCT after OC-1 infusion","definition_or_measurement_approach":"Measured as progression-free survival in the subgroup of patients who did not receive HSCT following OC-1 infusion; exact protocol definition not provided in source."}
• {"endpoint_text":"- Proportion of patients who received an HSCT post OC-1 infusion","definition_or_measurement_approach":"Measured as the proportion of patients who underwent hematopoietic stem cell transplant (HSCT) after OC-1 infusion."}
• {"endpoint_text":"- Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR. Genomic copy number integrations of the CAR in peripheral blood (PB) T cells and percentage of CD1a CAR-expressing T cells.","definition_or_measurement_approach":"Measured by flow cytometry and quantitative qPCR to assess genomic copy number integrations of CAR in peripheral blood T cells and percentage of CD1a CAR-expressing T cells."}

Spain

Earliest CTIS Part Ii Submission Date

24-03-2025

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

18

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Onechain Immunotherapeutics S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain