Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Recruiting now · Phase 1
Conditions studied: T-cell Acute Lymphoblastic Leukemia, Lymphoblastic T-Cell Lymphoma
In brief
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)
Key facts
- Study ID
- NCT05679895
- Run by
- OneChain Immunotherapeutics
- People needed
- 20
- Starts
- 2023-01-31
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- 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.
- Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- 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.
- The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
- Other non-controlled concomitant neoplasms.
Where it is running
- Hospital Clínic — Barcelona, Spain (enrolling)
- Hospital Sant Joan de Déu — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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