*August 2024*
- A fast track designation has been granted to Deltacel (KB-GDT-01) in combination with low-dose radiation therapy by the FDA.
- This indication is for patients with metastatic non–small cell lung cancer (NSCLC) who have progressed on 2 or more prior lines of standard-of-care therapy.
- The agent is currently undergoing evaluation in the phase 1 Deltacel-01 trial (NCT06069570).
The FDA has granted Deltacel a fast track designation when used in combination with low-dose radiation therapy for the treatment of patients with metastatic NSCLC who have progressed on 2 or more prior lines of standard-of-care therapy. This includes platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy.1
Deltacel is an allogeneic, off-the-shelf gamma delta T-cell (γδT) therapy made of donor-derived, unmodified γδT cells. The agent targets solid tumors through using the natural potency of γδT cells.
Currently, the phase 1, open-label Deltacel-01 trial is evaluating Deltacel in patients with stage IV NSCLC who have not responded to standard therapies. Interim safety and efficacy data from part 1 of the trial were reported on August 9, 2024, and demonstrated a progression-free survival (PFS) of 4.8 months (range, 2-8) among 5 evaluable patients.2 Data from this portion of the study support this fast track designation. Read more.
