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

Who is this study for? Patients with advanced pancreatic cancer
What treatments are being studied? Cyclophosphamide+Fludarabine+Mutant KRAS G12V-specific TCR transduced autologous T cells+Anti-PD-1 monoclonal antibody
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Shiwei Guo, Doctor
gestwa@163.com
+8618621500666
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2028-12
Participants
Target number of participants: 30
Treatments
Experimental: TCR Transduced T cell therapy
Pre-conditioning: Non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine~TCR transduced T cell infusion: mutant KRAS G12V-specific TCR transduced autologous T cells (1e9\~1e11). If the participant responds to the first infusion, the second or more infusions will be considered when the disease is progressing.~Anti-PD-1 therapy: anti-PD-1 will be administered if needed.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov

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