One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).
'A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP,' said
Dr.
Topline data from ILC 1
One patient had a complete response and also demonstrated a sustained reduction in serum AFP. This patient experienced disease progression, having developed new lesions at Week 32
Overall, nine patients have been treated as of the data cutoff, of those
Four patients have been treated with 5 billion or more transduced cells (three in Cohort 3 and one in the expansion phase): 1 patient with the complete response, 1 with stable disease (SD), and 2 had progressive disease (PD)
Five patients were previously treated in the first two dose cohorts with doses of 100 million and 1 billion transduced cells, respectively, and all patients had best responses of SD
ADP-A2AFP SPEAR T-cells were associated with an acceptable safety profile with no evidence of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
Evidence of dose-dependent persistence of ADP-A2AFP SPEAR T-cells post-infusion
Further translational evaluation is ongoing to understand indicators of response
All data summarized are for patients with HCC with a data cut-off of
Overview of Trial Design
This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with HCC or other AFP-expressing tumors who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
Dose escalation is complete, and this trial is enrolling in the expansion phase intended to treat up to 25 patients with doses up to 10 billion cells
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