Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors
Study Details
Study Description
Brief Summary
This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1*07:01).
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB107:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB107:01-restricted KRAS G12V reactive T-cell receptors (TCR).
Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient.
In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1*07:01).
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Providence Health & Services
Investigators
- Principal Investigator: Matthew Taylor, MD, Providence Health & Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020000471