Children older than 2 years or adults, male and female, with refractory or relapsed T-cell acute lymphoblastic leukaemia/lymphoblastic lymphoma (T-ALL/LL). MedDRA version: 21.1 Level: PT Classification code 10036546 Term: Precursor T-lymphoblastic lymphoma/leukaemia recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: OC-1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OC-1
Current Sponsor code: OC-1
Other descriptive name: Autologous T cells ex vivo modified with a lentiviral vector
Sponsors
OneChain Immunotherapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Children older than 2 years or adults, male and female in both groups. 2.Patients CD1a positive antigen blast expression =20%, either immunophenotypically (flow cytometry) or histologically confirmed. 3.R/R CD1a-positive T-ALL/LL patients, including morphologic or MRD-detectable (=1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines: -Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT) -Primary refractoriness, defined as either morphologic persistence or detectable MRD (=1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT. -Refractory first relapse. -Second or further relapse. 4.Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study. Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1.Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction. 2.Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD). 3.Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease. 4.Active bacterial, fungal or viral infection not controlled by adequate treatment. 5.Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection. 6.Women who are pregnant (urine/blood pregnancy test positive) or lactating. 7.Severe illness or medical condition, which would not permit the patient to be managed according to the protocol. 8.Suffering from a serious autoimmune disease or immunodeficiency disease. 9.The patient participated in other experimental drug clinical trial within 6 weeks prior to enrollment. 10.Other non-controlled concomitant neoplasms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of OC-1 in patients with primary relapsed/refractory CD1a-positive T-ALL/LL.;Secondary Objective: Other key objectives are to assess the preliminary efficacy and persistence of the product: - To describe the response to OC-1. - To describe the duration of the response after the administration of OC-1. - To describe the overall survival after the administration of OC-1. - To describe the persistence of OC-1 cells in peripheral blood after administration.;Primary end point(s): To assess the infusion of OC-1 safety on the basis of the following parameters: •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).;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •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.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Spain
Contacts
Public ContactResearch Project Management
OneChain Immunotherapeutics
Outcome results
None listed