Autologous ARTEMIS® T Cells to Treat Refractory/Relapsed Pediatric Liver Cancer
Grant Award Details
Grant Type:
Grant Number:
CLIN2-14338
Investigator(s):
Disease Focus:
Award Value:
$10,600,072
Status:
Active
Grant Application Details
Application Title:
Autologous ARTEMIS® T Cells to Treat Refractory/Relapsed Pediatric Liver Cancer
Public Abstract:
Therapeutic Candidate or Device
ET140203 T cells: engineered T-cell therapy whereby autologous T cells are modified to specifically target and kill AFP+/ HLA-A2+ cancer cells.
Indication
Pediatric subjects aged ≥ 1 year to ≤ 21 years who are AFP-positive/HLA-A2-positive and have relapsed/refractory (r/r) HB, HCN-NOS, or HCC.
Therapeutic Mechanism
ET140203 T-cell therapy is designed to target alpha-fetoprotein (AFP)-peptide/human leukocyte antigen (HLA)-A2 complexes expressed on liver cancer cells and specifically kill them via a natural TCR-signaling pathway with the addition of GPC3-guided co-stimulation.
Unmet Medical Need
There is no approved therapy in any line of treatment for any form of pediatric liver cancer. ET140203 T-cell therapy has great potential to improve the prognosis and survival outcome of pediatric subjects with r/r HB, HCN-NOS, or HCC and replace chemotherapy which has severe lifelong side effects.
Project Objective
Phase 1 trial completed.
Major Proposed Activities
ET140203 T cells: engineered T-cell therapy whereby autologous T cells are modified to specifically target and kill AFP+/ HLA-A2+ cancer cells.
Indication
Pediatric subjects aged ≥ 1 year to ≤ 21 years who are AFP-positive/HLA-A2-positive and have relapsed/refractory (r/r) HB, HCN-NOS, or HCC.
Therapeutic Mechanism
ET140203 T-cell therapy is designed to target alpha-fetoprotein (AFP)-peptide/human leukocyte antigen (HLA)-A2 complexes expressed on liver cancer cells and specifically kill them via a natural TCR-signaling pathway with the addition of GPC3-guided co-stimulation.
Unmet Medical Need
There is no approved therapy in any line of treatment for any form of pediatric liver cancer. ET140203 T-cell therapy has great potential to improve the prognosis and survival outcome of pediatric subjects with r/r HB, HCN-NOS, or HCC and replace chemotherapy which has severe lifelong side effects.
Project Objective
Phase 1 trial completed.
Major Proposed Activities
- Complete Phase 1, assess clinical safety and tolerability of ET140203 T cells and determine the recommended phase 2 dose.
- Activate UCSF as a clinical site. Promote trial awareness, DEI-focused outreach, enrollment, and retention efforts. Support trial operation.
- Manufacture the T-cell product to supply the proposed trial. Manufacture a lentiviral vector lot to supply the proposed trial.
Statement of Benefit to California:
ET140203 T-cell therapy will benefit California by serving as a potential treatment option for a sensitive patient population with an urgent and significant unmet medical need: children with relapsed/refractory liver cancer. This research effort will create jobs and stimulate economic growth by contributing to CA’s economy, advancing medical research, fostering a well-educated workforce, and driving progress in the field of medicine to improve healthcare outcomes for diverse patient populations.