Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2+
SponsorOneChain Immunotherapeutics
About this trial
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
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CD1a-CAR T
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
OneChain Immunotherapeutics
Lead sponsor
BioClever 2005 S.L.
Collaborator
Hospital Clinic of Barcelona
Collaborator
Hospital Sant Joan de Deu
Collaborator
Astrum CRO, S.L.
Collaborator
Source ClinicalTrials.gov