Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Fludarabine
- Mutant KRAS G12V-specific TCR transduced autologous T cells
- Anti-PD-1 monoclonal antibody
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov