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
OneChain Immunotherapeutics
20 participants
Jan 31, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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 Criteria10
- 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.
Interventions
Autologous 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
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05679895