T-cell Acute Lymphoblastic Leukemia, T-cell acute lymphoblastic Lymphoma
Conditions
Brief summary
Number of adverse events grade III-IV, related or possibly related, using Common Toxicity Criteria for Adverse Events (CTCAE) version 5, 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
Detailed description
Overall survival following OC-1 cell therapy infusion, Progression-free survival, Progression-free survival in patients who did not received HSCT after OC-1 infusion, Proportion of patients who received an HSCT post OC-1 infusion, 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.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events grade III-IV, related or possibly related, using Common Toxicity Criteria for Adverse Events (CTCAE) version 5, 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival following OC-1 cell therapy infusion, Progression-free survival, Progression-free survival in patients who did not received HSCT after OC-1 infusion, Proportion of patients who received an HSCT post OC-1 infusion, 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. | — |
Countries
Spain