drugset / Trial / NCT05544968
Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
Non-randomizedSequentialOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2026-03-04
- Primary completion
- 2028-01
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD30 biAb-AATC | Cell therapy | 40 cells/kg | — |
| Subject | CD30 biAb-AATC | Cell therapy | 80 cells/kg | — |
| Subject | CD30 biAb-AATC | Cell therapy | 120 cells/kg | — |
| Subject | CD30 biAb-AATC | Cell therapy | 160 cells/kg | — |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |