RecruitingPhase 1Phase 2NCT04146298

Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer

Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer


Sponsor

Changhai Hospital

Enrollment

30 participants

Start Date

Oct 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge immune cell therapy for advanced pancreatic cancer. The treatment takes a patient's own T cells (immune cells), engineers them in the lab to recognize a specific cancer mutation called KRAS G12V, then infuses them back to attack the cancer. This approach is highly personalized because it targets a mutation found in many pancreatic cancers. **You may be eligible if...** - You have advanced or metastatic pancreatic cancer confirmed by biopsy - Your tumor has the KRAS G12V mutation (or a similar mutation in HRAS or NRAS) - You carry a specific immune marker called HLA-A*11:01 - You are between 18 and 75 years old - You are in good physical condition (ECOG 0 or 1) - You have received standard chemotherapy previously **You may NOT be eligible if...** - Your tumor does not have the required mutation - You do not carry the HLA-A*11:01 marker - You are not willing to use birth control during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Cyclophosphamide will be administered prior to cell infusion.

DRUGFludarabine

Fludarabine will be administered prior to cell infusion.

BIOLOGICALMutant KRAS G12V-specific TCR transduced autologous T cells

After preconditioning regimen, T cells will be infused to the patient intravenously in the Patient Care Unit over approximately 30 to 50 minutes.

DRUGAnti-PD-1 monoclonal antibody

During the treatment, anti-PD-1 monoclonal antibody will be administered if needed.


Locations(1)

Changhai Hospital

Shanghai, China

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NCT04146298


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