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New treatment option for Pancreatic Cancer
Official title Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT04146298
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard...
- Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods.
- Patients must be HLA-A\ 11:01.
- Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in...
- Patients between 18 to 75 years old are eligible.
You likely can't join if
- Women who are pregnant or breastfeeding.
- Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or HIV).
- Patients with active systemic infections, coagulation disorders, or any other major medical illnesses.
- Patients with concurrent opportunistic infections.
- Patients on concurrent systemic steroid therapy.
- Patients with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide...
See the full eligibility criteria
- Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received...
- Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods.
- Patients must be HLA-A\ 11:01.
- Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in diameter.
- Patients between 18 to 75 years old are eligible.
- Patients should have good clinical performance status (ECOG 0 or 1).
- Patients must practice birth control once enrolled into the study and for up to four months after therapy.
- Patients must be seronegative for HIV antibody.
- Patients must be seronegative for hepatitis B surface antigen and core antibody (or HBV non-detectable by QPCR).
- Patients must be seronegative for hepatitis C antibody (or HCV non-detectable by QPCR).
- Baseline hematology criteria:
- Absolute neutrophil count of at least 1000/mm\^3.
- White blood cell count of at least 3000/mm\^3.
- Platelet count of at least 100,000/mm\^3.
- Hemoglobin \> 8.0 g/dL.
- Baseline chemistry criteria:
- Serum ALT/AST less than or equal to 3.0 x ULN.
- Total bilirubin less than or equal to 1.5 mg/dL, unless the patient has Gilbert's Syndrome in which case total bilirubin must be less than or equal to 3.0 mg/dL.
- Serum creatinine less than or equal to 1.6 mg/dL.
- Anticipated lifespan greater than 12 weeks.
- Patients must be willing and able to comply with all study-related procedures and follow-up requirements.
- Patients must be able to understand and sign a written Informed Consent Document as well as a durable power of attorney.
- Women who are pregnant or breastfeeding.
- Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or HIV).
- Patients with active systemic infections, coagulation disorders, or any other major medical illnesses.
- Patients with concurrent opportunistic infections.
- Patients on concurrent systemic steroid therapy.
- Patients with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine).
- Patients with active coronary ischemic symptoms.
- Patients who are receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.