This is a single-center, open-label, single-arm, dose-escalation study aimed at evaluating the safety and preliminary efficacy of KRAS-specific autologous TCR-T cells in patients with advanced solid tumors harboring KRAS G12V mutation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients aged 18-70 years.
* Histologically or cytologically confirmed advanced solid tumors (e.g., colorectal cancer, pancreatic cancer, NSCLC) with KRAS G12V mutations and HLA-A\*11:01 genotype.
* Failed standard therapies or no effective treatment available.
* ECOG performance status of 0-1.
* Life expectancy of ≥3 months.
* Presence of at least one measurable lesion as defined by RECIST 1.1 criteria.
* Female patients of childbearing potential must agree to use highly effective contraceptive methods during the study and for at least 6 months after the last dose. A negative pregnancy test within 7 days prior to treatment initiation is required.
* Written informed consent provided by the patient, with an expectation of compliance with study procedures.
Exclusion Criteria:
* Prior treatment with gene-modified T-cell therapies.
* Current treatment with T-cell suppressive agents (e.g., cyclophosphamide, FK506, tripterygium glycosides) or T-cell stimulants.
* Chemotherapy, targeted therapy, immunotherapy, or investigational drugs administered within 2 weeks, or radiotherapy within 4 weeks prior to enrollment.
* Significant organ dysfunction, as evidenced by:
* leukocytes\<3.0 x 109/L
* absolute neutrophil count \>1.5 x 109/L
* hemoglobin\<90g/L
* platelets \<100 x 109/L
* Creatinine\>1.5×ULN or creatinine clearance \<50mL/min
* lymphocytes\<0.5 x 109/L
* total bilirubin\>3×ULN; ALT/AST\>3×ULN (or \>5× ULN in patients with liver metastases)
* INR/APTT\>1.5×ULN
* SpO2≤93%
* Presence of serious diseases and comorbidities, including but not limited to: severe heart disease, cerebrovascular disease, seizures, poorly controlled diabetes (such as Type 1 diabetes or insulin-dependent diabetes), pancreatic dysfunction, severe infections, active gastrointestinal ulcers, gastrointestinal bleeding, mechanical or paralytic bowel obstruction, pulmonary fibrosis, renal failure, respiratory failure, etc.
* History of severe cardiovascular diseases within the past 6 months, including but not limited to: myocardial infarction, severe or unstable angina, coronary artery or peripheral artery bypass surgery, New York Heart Association (NYHA) Class III or IV heart failure, etc.
* Left ventricular ejection fraction (LVEF) \< 50%.
* Symptomatic brain metastases unless stabilized with prior treatment (e.g., surgery or radiotherapy).
* Known history of myelodysplastic syndrome, lymphoma, or other malignancies.
* Known allergy to albumin, investigational drugs, or their excipients.
* Active autoimmune diseases, including but not limited to acquired/congenital immunodeficiency, organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, or inflammatory bowel disease.
* Active hepatitis B, hepatitis C, or HIV infection.
* Pregnancy or breastfeeding.
* Uncontrolled mental or neurological disorders.
* Any condition deemed unsuitable for study participation by the investigator.
Primary outcome measure(s)
DLT (Dose Limiting Toxicity) Incidence Rate — 28 days
Explore the MTD (Maximum Tolerated Dose) or Subsequent Expansion Dose — 28 days
Safety Assessment: Changes in patient safety parameters at various follow-up time points after TCR-T infusion, as well as the incidence of adverse events (AEs), which were graded according to the CTCAE V6.0 severity scale. — 2 years
Trial sites (1)
Facility
City
Region
Status
Beijing Ditan Hospital, Capital Medical University
Beijing
Beijing Municipality
More Corregene Biotechnology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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