Phase I Study of Anti-CD30 Bispecific Antibody-Armed Autologous T-Cell Therapy with GM-CSF in Adults with Relapsed or Refractory CD30-Positive Blood Cancers

What this Trial Is About

Researchers are studying a new immunotherapy treatment for adults with relapsed or refractory CD30-positive blood cancers. This Phase I trial aims to assess the safety, feasibility, and early effects of a novel therapy that uses the patients own T-cells armed with a bispecific antibody targeting CD30 and CD3. The study addresses cancers such as Hodgkins lymphoma, non-Hodgkin lymphoma, and certain leukemias where current treatments have limited success. The treatment involves collecting T-cells from patients, followed by a recommended 21-day bridging chemotherapy while the therapy is prepared and quality-checked. Patients then receive weekly infusions of the dose-escalating CD30 bispecific antibody-armed activated T-cells CD30 biAb-AATC along with twice-weekly subcutaneous injections of GM-CSF, a drug that supports white blood cell formation. This regimen is given in 4-week cycles for up to two cycles, with dosing increased stepwise to find the safest and most effective dose. Participants will undergo regular assessments including monitoring for side effects and measuring the maximum tolerated dose over two years. Researchers will evaluate disease response through imaging and lab tests, as well as organ function and performance status. The study includes close observation of treatment effects, with follow-up visits and safety monitoring throughout the treatment period and beyond. Total participation length varies based on individual response and dosing schedule.

Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies