AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllChanghai Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 surgery and adjuvant chemotherapy previously). * 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. Exclusion Criteria: * 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.
๐Ÿ’Š

What it tests

  • Cyclophosphamide
  • Fludarabine
  • Mutant KRAS G12V-specific TCR transduced autologous T cells
  • Anti-PD-1 monoclonal antibody
๐Ÿ“

Where

1 site
Changhai Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy