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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD1a-CAR T
Biological/VaccineAutologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express CD1a chimeric antigen receptor administered by intravenous infusion following a dose-escalation approach
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental: CD1a-CAR TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of adverse events grade III-IV
Number of adverse events grade III-IV using common toxicity criteria (CTC)
Time frame
1 year particularly the first 28 days after infusion2
Incidence of severe Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS)
Incidence of severe Cytokine release syndrome (CRS) (≥ grade III) and Immune effector cell-associated neurotoxicity syndrome (ICANS) (≥ grade II)
Time frame
1 year particularly the first 28 days after infusion3
Non-relapse treatment-related mortality (NRM)
Non-relapse treatment-related mortality (NRM)
Time frame
1 year4
Number of adverse events of special interest (AESI)
Number of adverse events of special interest (AESI)
Time frame
1 yearSecondary outcomes
1
Remission rate
Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.
Time frame
1 year2
Response rates
Percentage of patients presenting CR, CRi, morphologic leukaemia-free status (MLFS), and no remission (NR). In the presence of extramedullary disease, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe the response.
Time frame
1 year3
Complete remission duration (CRD)
The time from the first documented date of complete remission until disease progression (in days)
Time frame
1 year4
Duration of remission
The duration of the remission will be assessed from the first documented date of remission status until progression (in days)
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
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