KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors (NCT06767046) | Clinical Trial Compass
Active — Not RecruitingPhase 1
KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors
China8 participantsStarted 2025-02-18
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 1.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 metastas…
What they're measuring
1
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs)