NCT05679895RecruitingPhase 1
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Dec 2022
- Start date
- 31 Jan 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- OneChain Immunotherapeutics
- NCT number
- NCT05679895
- EU CT number
- 2024-514591-40-00
- EudraCT number
- 2021-002333-42
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 31 Jan 2023 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
- Other non-controlled concomitant neoplasms.
Other illness
- 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.
Lab values
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), \<45%), pulmonary, liver, renal or CNS dysfunction.
Other
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
Who the study is looking for
- 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.
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.