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)

Phase 1

Conditions: T-cell Acute Lymphoblastic Leukemia, T-cell acute lymphoblastic Lymphoma
MedDRA version: 21.1Level: LLTClassification code: 10025245Term: Lymphoblastic lymphoma (Precursor T-lymphoblastic lymphoma/leukaemia) recurrent Class: 10029104
MedDRA version: 21.1Level: LLTClassification code: 10066105Term: T-cell lymphoblastic leukaemia acute Class: 10029104
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

Registration Number: CTIS2024-514591-40-00

Lead Sponsor: Onechain Immunotherapeutics S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.