KRAS G12V Mutant Advanced Epithelial CancersNCT05389514
Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors
A study testing Cyclophosphamide, Gemcitabine and Pembrolizumab in people with KRAS G12V Mutant Advanced Epithelial Cancers, run by Providence Health & Services.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS G12V Mutant Advanced Epithelial Cancers
- What is being tested?
- Cyclophosphamide, Gemcitabine and Pembrolizumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)
About this study
Official title: Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells
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).
Read the 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-DRB1*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1*07:01-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).
- Being tested
- Cyclophosphamide, Gemcitabine, Pembrolizumab, Cell Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Cytoxan Lyophilized, Cy
Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.
GemcitabineDrug
Also called Gemzar
Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.
PembrolizumabDrug
Also called KEYTRUDA, MK-3475
Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks.
Cell InfusionBiological
Patient's T cells will be administered at a dose of between 1 x 10^9 to 5.0 x 10^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers.
The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12V Mutant Advanced Epithelial CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Taylor, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389514
- Sponsor's protocol ID
- 2020000471
- Status last verified
- Sep 2026
- First submitted
- 19 May 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells
- ClinicalTrials.gov ID
- NCT05389514
- Acronym / sponsor ID
- 2020000471
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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-DRB1*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1*07:01-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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, Cytoxan Lyophilized, CyPatients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3. | Drug | – |
| GemcitabineAlso: GemzarPatients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2. | Drug | – |
| PembrolizumabAlso: KEYTRUDA, MK-3475Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks. | Drug | – |
| Cell InfusionPatient's T cells will be administered at a dose of between 1 x 10^9 to 5.0 x 10^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers. The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Taylor, MD principal investigator
Providence Health & Services
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide, Gemcitabine and Pembrolizumab in people with KRAS G12V Mutant Advanced Epithelial Cancers, run by Providence Health & Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.