Catalonia.health member biotech company OneChain Immunotherapeutics has announced promising interim results from its ongoing clinical trial with OC-1, its CAR-T therapy, in patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LL), a rare and aggressive blood cancer that affects both children and adults. The data were presented on June 17 at the 2026 Congress of the European Hematology Association (EHA).
Phase 1 trial results
The data comes from the Phase 1 study (EU CT Number 2024-514591-40-00), designed to evaluate the safety and tolerability of OC-1, initial clinical efficacy and determine appropriate dose levels. The two lowest dose levels have been evaluated to date, and the majority of evaluable patients have responded to treatment, some with a complete response. OC-1 has shown a manageable safety profile at this early stage of development, with side effects consistent with those typical of CAR-T therapies and no serious infections reported in treated patients.
The trial is being conducted at Hospital Sant Joan de Déu and Hospital Clínic Barcelona, and continues to recruit patients as the study progresses to higher dose levels, in both pediatric and adult populations.
An unmet medical need in T-cell diseases
T-cell acute lymphoblastic leukemia/lymphoma is a rare and aggressive cancer that, although responsive to initial treatment in many cases, carries a devastating prognosis when it relapses or becomes resistant to therapy. In these patients, the available therapeutic options are very limited. Despite advances in CAR-T therapies in some blood cancers, progress in T-cell diseases has been slower due to scientific and manufacturing challenges specific to this indication.
Statements by Principal Investigators
Dr. Susana Rives, principal investigator of the study at the Pediatric Cancer Center Barcelona (PCCB) of Hospital Sant Joan de Déu, has pointed out that the treatment options for patients with relapsed or refractory T-cell leukemia or lymphoma are extremely limited, and has emphasized that these provisional results suggest that OC-1 could offer a new opportunity for patients with a very adverse prognosis.
Dr. Núria Martínez-Cibrian, second principal researcher at the Hematology and Hemotherapy Service of the Hospital Clínic de Barcelona, has emphasized that the CARxALL trial is the first study in humans and that, therefore, safety is a priority. It has indicated that the toxicities observed in the infused patients have been manageable and that no deaths attributed to the experimental treatment have been recorded.
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