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Clinical Trials in China / NCT07826585
Active, not recruiting Phase 1

Treatment of Patients With Advanced Solid Tumors Using CRTKVA11-03 TCR-T Cell Injection

NCT07826585 · tracked via the Priya Life Science China tracker
Sponsor
Corregene Biotechnology Co., Ltd
Phase
Phase 1
Started
2026-03-26
Last updated
2026-09-17

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CRTKVA11-03 TCR-T Cell Injection

CRTKVA11-03 TCR-T Cell Injection: Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :CRTKVA11-03 TCR-T Cell Injection

Study 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.

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)

Trial sites (1)

FacilityCityRegionStatus
Beijing Ditan Hospital, Capital Medical University Beijing Beijing Municipality

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Official registry record

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.

View NCT07826585 on ClinicalTrials.gov ↗ ← All trials in China