Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors

NCT07396090 | Not Yet Recruiting

• 1 other identifier: CAT-101
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, immunogenicity and preliminary efficacy of engineered dendritic cells（eDCs）loaded with mKRAS antigen (CAT-101) alone or in combination with Tislelizumab (anti-PD-1 monoclonal antibody) among participants with KRAS-G12C/D/R/V mutated advanced pancreatic cancer and other solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.

  up to 24 months

Secondary Outcomes (8)

• Objective Response Rate

  up to 24 months

• Immunogenicity of eDC-KRAS vaccine

  up to 24 months

• Rate of MRD Clearance

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Duration of Relief

  up to 24 months

Study Arms (1)

Participant Group

EXPERIMENTAL

mKRAS antigen-loaded engineered dendritic cells (eDCs, designated as CAT-101)

Biological: eDC-KRAS vaccine; Drug: Tislelizumab

Interventions

eDC-KRAS vaccine BIOLOGICAL

intravenous injection

Participant Group

Tislelizumab DRUG

intravenous injection

Participant Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (8) Participants must have measurable lesions detected by computed tomography (CT) or magnetic resonance imaging (MRI) (according to iRECIST criteria);

You may not qualify if:

• (2)Patients received proteasome inhibitors and immunomodulators, radiotherapy, or approved Chinese traditional medicine within 2 weeks or 5 half-lives prior to the first vaccination(whichever is shorter), (3) patients with meningeal, brainstem, or spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Participants with asymptomatic brain metastases within 4 weeks before the first vaccination and who do not require steroid treatment for at least 14 days are eligible for enrolment.
• (4) patients with active second primary malignancy; however, patients received curative treatment and without known active disease for ≥2 years or non-melanoma skin cancer patients who received adequately treatment and with no evidence of disease will be eligible for study entry (5) patients with severe uncontrolled infection (bacterial, viral, fungal, etc.) during the screening period; (6) known positive test results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range or positive for human immunodeficiency virus (HIV) antibody; positive syphilis test within 6 months prior to the vaccinations.
• (7)Patients with symptomatic heart failure or other cardiac diseases such as severe arrhythmias:
• New York Heart Association (NYHA) Class III or IV congestive heart failure;
• Myocardial infarction or coronary artery bypass graft (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF;
• Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding vasovagal or dehydration-related causes);
• History of severe non-ischemic cardiomyopathy; （8）patients with other diseases, including:
• Primary immunodeficiency;
• Stroke or seizure within 6 months prior to screening;
• Significant clinical evidence of dementia or altered mental status;
• Parkinson's disease or Parkinson-like movement disorders or history thereof;
• Uncontrolled hypothyroidism or hyperthyroidism; (9)Surgery within 2 weeks prior to the vaccination or planned surgery within 2 weeks after the vaccination, excluding local anesthesia; （10）Uncontrolled hypertension, hypercalcemia, or diabetes; （11）Vaccination with live attenuated vaccines within 1 month prior to the first infusion; （12） Patients who have undergone long-term systemic corticosteroid therapy; （13）Known severe allergic reactions to eDC products or their formulation components (e.g., albumin, IL-2) （14）eDC-KRAS preparation failed; （15）Researchers believe that other reasons are not suitable for clinical trials

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Interventions

tislelizumab

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Office of Clinical Trial Center, CancerIHCAMS

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-10