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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children older than 2 years and adults with T-cell acute lymphoblastic leukemia or lymphoma that came back or did not respond to treatment, and whose cancer cells carry the CD1a marker.
- Age
- Older than 2 years (children and adults).
- Sex
- Men and women.
- Disease stage
- Relapsed or refractory T-ALL/LL: no complete remission after at least two cycles of chemotherapy, a first or later relapse, relapse after allogeneic stem cell transplant, or primary refractory disease that rules out a transplant.
- Earlier treatment
- At least two cycles of chemotherapy or at least one standard first-line therapy; allogeneic stem cell transplant (allo-HSCT) is allowed, but not within the last 3 months. No other experimental drug trial within 6 weeks before the OC-1 infusion.
- Biomarker or test result
- CD1a antigen on at least 20% of the blast cells, confirmed by flow cytometry or histology.
Main reasons for not taking part
- Serious heart, lung, liver, kidney or nervous system problems (for example LVEF below 45%)
- Allo-HSCT less than 3 months ago, or still needing treatment for graft versus host disease
- Known HIV, active hepatitis B or hepatitis C infection
- Pregnant or breastfeeding women
- Active infection not controlled by treatment, or serious autoimmune or immunodeficiency disease
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.