CD30 Bispecific Antibody-Armed T Cells

anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells

Hematopoietic agent that helps form white blood cells.

Non-randomized, single arm, dose escalating, Phase I study evaluating the feasibility and safety of a novel anti-CD30 biAb-AATC product for adult patients with relapsed/refractory CD30+ cancer. Following T-cell collection patients are recommended to receive a bridging chemotherapy for 21 days while product is being generated and quality control assessed.

This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).

Registro actualizado en ClinicalTrials.gov →

• Diagnosis: Patients must have had histologic or cytologic verification of the below qualified malignancy. The pathology report for the diagnosis under which the patient is being enrolled and associated molecular diagnostic reports must be submitted.
• i. Second or greater recurrence or refractory to at least 2 prior therapeutic regimens.
• ii. Any relapse after HSCT.
• ii. Any relapse after HSCT or CAR T cell therapy.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.