Tests CD1a-CAR T cell therapy in children and adults with relapsed T-cell leukemia
Tests CD1a-CAR T cell therapy in people aged 2 and older with returning T-cell leukemia.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Key facts
- Where
- Barcelona and Esplugues de Llobregat, SpainSee the 2 sites
- Phase
- Phase 1
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- OneChain Immunotherapeutics
- Trial code
- NCT05679895EU 2024-514591-40-00
- Record updated
- 11 March 2026
- Original description
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)Read full original descriptionShow less
Safety and Efficacy of hCD1a-CAR T (OC-1) Therapy, in Patients With Relapsed/Refractory (R/R) T-cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LL
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)
Inclusion: Children older than 2 years or adults, male and female in both groups; Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed; 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; Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
Exclusion: The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion; Other non-controlled concomitant neoplasms; Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD); Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease; Active bacterial, fungal or viral infection not controlled by adequate treatment; Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection; Severe illness or medical condition, which would not permit the patient to be managed according to the protocol; Suffering from a serious autoimmune disease or immunodeficiency disease; Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction; Women who are pregnant (urine/blood pregnancy test positive) or lactating.