First in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation study to assess the safety and efficacy of CD1a-CAR T therapy in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express CD1a chimeric antigen receptor administered by intravenous infusion following a dose-escalation approach
Hospital Clínic
Barcelona, Spain
RECRUITINGHospital Sant Joan de Déu
Barcelona, Spain
RECRUITINGNumber of adverse events grade III-IV
Number of adverse events grade III-IV using common toxicity criteria (CTC)
Time frame: 1 year particularly the first 28 days after infusion
Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)
Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)
Time frame: 1 year particularly the first 28 days after infusion
Non-relapse treatment-related mortality (NRM)
Non-relapse treatment-related mortality (NRM)
Time frame: 1 year
Number of adverse events of special interest (AESI)
Number of adverse events of special interest (AESI)
Time frame: 1 year
Assessment of the immunological homeostasis
Assessment of the immunological homeostasis, through the identification of lymphocytes subpopulations by flow cytometry at each study timepoint.
Time frame: 1 year
Incidence of the treatment-related dermatological events
Incidence of the treatment-related dermatological events
Time frame: 1 year
Number of patients developing dose limiting toxicity (DLT)
Number of patients developing dose limiting toxicity (DLT)
Time frame: first 28 days after infusion
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Remission rate
Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.
Time frame: 1 year
Response rates
Percentage of patients presenting CR, CRi, morphologic leukaemia-free status (MLFS), and no remission (NR). In the presence of extramedullary disease, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe the response.
Time frame: 1 year
Complete remission duration (CRD)
The time from the first documented date of complete remission until disease progression (in days)
Time frame: 1 year
Duration of remission
The duration of the remission will be assessed from the first documented date of remission status until progression (in days)
Time frame: 1 year
Minimal residual disease (MRD) response
Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).
Time frame: 1 year
Progression-free survival (PFS)
Time since the first OC-1 administration to the documented loss of response.
Time frame: 1 year
Overall survival
Overall survival time since first OC-1 administration to date of death.
Time frame: 1 year
Persistence of OC-1
• 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.
Time frame: 1 year