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)_CARxALL - OC-01-21001- CARxA

Onechain Immunotherapeutics S.L.0 个研究点目标入组 20 人开始时间: 2024年7月5日最近更新: 2024年7月22日

试验速览

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•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, including morphologic or MRD-detectable (=1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines: Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT) Primary refractoriness, defined as either morphologic persistence or detectable MRD (=1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT. Refractory first relapse. Second or further relapse., Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.

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

发起方

Onechain Immunotherapeutics S.L.