OC-1 / OneChain Immunotherap - LARVOL DELTA

SAFETY AND EFFICACY OF HCD1A-CAR T (OC-1) THERAPY, IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) T-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA/LYMPHOMA (T-ALL/LL): A PRE-SPECIFIED INTERIM ANALYSIS. (EHA 2026) - "Lymphodepletion consists of fludarabine 30mg/m 2 /day and cyclophosphamide 300mg/m 2 /day on days -6 to -4...Among infused patients median age was 24 years (range 11-53), 78% were male, median prior lines were 3 (range 2-6), 67% were exposed to nelarabine and 44% had a previous alloHSCT...A high response rate has been seen with OC-1 in a heavily treated population; however, relapses were the main cause of treatment failure. The trial continues to recruit patients for DL3 and DL4 as there have been no safety concerns and responses have been observed."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Metabolic Disorders • Neutropenia • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Thrombocytopenia • CD1a

OC-01-23002: Long-term Follow-up study for relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL) patients previously treated with OC-1 cells. (clinicaltrialsregister.eu) - P2/3 | N=20 | Recruiting | Sponsor: Onechain Immunotherapeutics S.L. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma

CARxALL: Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: OneChain Immunotherapeutics | N=12 ➔ 20 | Trial completion date: Jun 2027 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma

CARxALL: Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: OneChain Immunotherapeutics | Trial completion date: Jan 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma

OneChain’s CAR T trial treats its first cortical T-cell ALL patient (PharmaTimes) - "OneChain Immunotherapeutics (OCI)...has announced that the CARxALL clinical trial has dosed its first cortical T-cell acute lymphoblastic leukaemia (coT-ALL) patient with OC-1, a CAR T therapy."

Trial status • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

FDA designates OneChain Immunotherapeutics' OC-1 as orphan drug [Google translation] (Biotech Spain) - "OneChain Immunotherapeutics, based in Barcelona Science Park, has obtained orphan drug designation from the US Food and Drug Administration (FDA) for OC-1, a CAR T therapy for the treatment of acute lymphoblastic leukemia. The company, which is part of the first generation of companies accelerated in the BCN Health Booster, has already started the CARxALL clinical trial to evaluate the safety and effectiveness of the compound in humans."

Orphan drug • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

CARxALL: Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: OneChain Immunotherapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma

CARxALL: Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: OneChain Immunotherapeutics

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma