Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Trial Parameters
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria 1. Children older than 2 years or adults, male and female in both groups. 2. Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed. 3. R/R CD1a-positive T-ALL/LL patients defined as: * Failure to achieve morphological complete remission (\> 5% bone marrow blasts) or persistence of extramedullary disease after at least two cycles of chemotherapy. * First or subsequent relapse, including morphologic or MRD-detectable (≥1x10-4 ) bone marrow and/or extramedullary relapses after at least one standard frontline therapy. * Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT). * Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4 ) after at least two cycles of chemotherapy, making the patient not candidate for allo-HSCT. 4. Patient without reproductive capacity or else, commitment to the use of a highly effective method of contracepti