An expanded access treatment program using genetically engineered immune cells to attack a specific cancer-driving mutation called KRAS G12D is currently accepting adults with advanced or metastatic solid tumors at Providence Cancer Institute.
KRAS is the most commonly mutated gene in human cancer. For decades, scientists considered it "undruggable" because of its shape, which made it hard to design drugs that could target it.
The most common version of the mutation, G12D, has no approved targeted therapy. G12D shows up in a large share of pancreatic cancers and in some cases of colorectal tumors, two diseases that are hard to treat once they have spread.
Researchers at Providence Cancer Institute previously showed that engineered immune cells could shrink tumors in patients with metastatic pancreatic cancer whose tumors had the G12D mutation. Their success offered proof this approach can work.
The new program currently offered at Providence builds on that early success with an improved, faster way of making the treatment.
Who might benefit?
This treatment is for adults with advanced or metastatic solid tumors whose cancer:
-
- Tests positive for the KRAS G12D mutation, confirmed by an approved lab test, and
- Has a matching immune system marker called HLA-A*11:01 and/or HLA-C*08:02 (a type of "ID tag" some people's cells carry that the engineered T cells need to recognize the tumor)
Because both the mutation and the immune marker must be present, only a small subset of patients qualify. Eligible cancer types include:
-
- Colorectal
- Pancreatic
- Non-small cell lung (NSCL)
- Esophageal/gastric
- Small bowel
- Appendiceal and biliary tract cancers
Each cancer type has its own requirement for what standard treatments a patient must have already tried.
How it works
The therapy in this program uses a method called adoptive T-cell therapy. This is how it works:
-
- Collect: Doctors draw blood and separate T cells through a process called leukapheresis. (T cells are the immune system's "soldier" cells.)
- Engineer: In the lab, those T cells are genetically modified to carry a new radar system, called a T-cell receptor, that is built specifically to spot cells carrying the KRAS G12D mutation. Because this mutation exists only in cancer cells, the therapy is designed to avoid attacking healthy tissue.
- Grow: The engineered cells are multiplied into the billions using a new, 10-day lab process (faster than the older one-month method). Lab testing suggests these "younger" cells may work better at killing tumor cells.
- Prepare the body: Before the cells are given back, patients receive a short course of low dose chemotherapy (cyclophosphamide and fludarabine) to temporarily clear out other immune cells, giving the new cells room to work.
- Infuse: The engineered T cells are returned to the patient through an IV, in the hospital, where the care team monitors for side effects like infusion reactions or cytokine release syndrome (a temporary, flu-like immune reaction that can occur when T cells become highly active).
Patients are followed closely afterward with regular blood tests, scans and clinic visits, with survival tracked for up to five years.
Accepting patients nowProvidence Cancer Institute is currently accepting patients into this treatment program. Binbin Zheng, M.D., is the principal investigator. Because eligibility depends on both a tumor's genetic profile and a patient's immune marker type, interested patients and their oncologists are encouraged to contact our research team to discuss testing and eligibility. |
|
To refer a patient:
- Call 503-215-1979
- Send an email
Find out more about the study
IND for treatment of patients with advanced cancer using T cells engineered to express T-cell receptors (TCR) targeting mutant KRAS
Find out about other clinical trials at Providence Cancer Institute.
Related news
hold for trial 1 link
Colonoscopies finding a high rate of early onset colorectal cancer, Providence study finds
Adoptive cell therapy: Phase III study open for people with advanced melanoma
