T-cell Acute Lymphoblastic Leukemia, T-cell acute lymphoblastic Lymphoma
Conditions
Brief summary
Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5., Incidence of severe Cytokine release syndrome (CRS) # grade III and Immune effector cell-associated neurotoxicity syndrome (ICANS) # grade II, Proportion of patients with non-relapse, treatment-related mortality (NRM), Number of adverse events of special interest (AESI), Assessment of the immunological homeostasis, through the description of lymphocytes subpopulations at each study timepoint., Incidence of severe (#3) treatment-related dermatological events., Number of patients developing dose limiting toxicity (DLT)
Detailed description
Remission rate: Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment, Duration of remission: The duration of the remission will be assessed from the first documented date of remission status until progression (in days), Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4)., Progression-free survival: time since the first infusion to the documented loss of response. In patients not presenting a CR or CRi progression free survival will be zero, Overall survival time since first infusion to date of death, Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR
Interventions
DRUGhCD1a-CAR T
Sponsors
Onechain Immunotherapeutics S.L.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5., Incidence of severe Cytokine release syndrome (CRS) # grade III and Immune effector cell-associated neurotoxicity syndrome (ICANS) # grade II, Proportion of patients with non-relapse, treatment-related mortality (NRM), Number of adverse events of special interest (AESI), Assessment of the immunological homeostasis, through the description of lymphocytes subpopulations at each study timepoint., Incidence of severe (#3) treatment-related dermatological events., Number of patients developing dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate: Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment, Duration of remission: The duration of the remission will be assessed from the first documented date of remission status until progression (in days), Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4)., Progression-free survival: time since the first infusion to the documented loss of response. In patients not presenting a CR or CRi progression free survival will be zero, Overall survival time since first infusion to date of death, Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR | — |
Countries
Spain
Outcome results
None listed