Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

Korábbi kezelés

• The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
• Other non-controlled concomitant neoplasms.

Más betegség

• 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.

Laborértékek

• Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.

Egyéb

• Women who are pregnant (urine/blood pregnancy test positive) or lactating.

• 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.