Actively Recruiting
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors
Led by Henan Cancer Hospital · Updated on 2025-12-16
30
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
At present, there is an urgent need for new drugs for KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002. Previous similar studies suggest the feasibility of TCR-T treatment, and measures have been taken to ensure the safe administration of RE002 and the close monitoring and management of adverse events. To sum up, RE002 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.
CONDITIONS
Official Title
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Advanced malignant solid tumors with confirmed pathological diagnosis
- Standard therapies have failed, are not tolerated, or no effective treatments exist
- At least one measurable tumor lesion
- Positive for HLA-A*11:01 and carrying KRAS G12D mutation confirmed by tumor gene testing
- Eastern Cooperative Oncology Group (ECOG) score of 0-1 and expected survival greater than 6 months
- Left ventricular ejection fraction at least 50% by cardiac ultrasound
- Laboratory results within specified limits for blood counts, liver and kidney function, and coagulation parameters
- Women of childbearing potential must use effective contraception for at least 12 months and have a negative pregnancy test within 14 days before treatment
- Men must agree to use effective contraception from study start to at least 12 months after T cell infusion
- Willingness and ability to attend regular study visits and assessments
You will not qualify if you...
- Received major surgery, chemotherapy, large-area radiotherapy, immunotherapy, or biological anti-tumor therapy within 4 weeks before the trial
- Previous use of drugs targeting KRAS G12D mutations or participation in similar cell therapy trials
- Known allergies to ingredients used in the trial such as dimethyl sulfoxide, cyclophosphamide, or fludarabine
- Unrecovered adverse reactions from previous treatments above Grade 2 CTCAE v5.0
- Uncontrolled hypertension or significant cardiovascular/cerebrovascular diseases including recent stroke, heart attack, unstable angina, or severe arrhythmias
- Serious organic diseases or mental disorders
- Active systemic infections including tuberculosis, HIV, or clinically active hepatitis A, B, or C
- History of inflammatory bowel disease or autoimmune diseases deemed unsuitable by the researcher
- Use of certain immunosuppressive or immunomodulatory drugs within 4 weeks before or during the study
- Brain metastasis with symptoms or requiring steroids/antiepileptics, meningitis, or meningeal metastasis
- Bleeding or thromboembolism risks including recent serious events or bleeding tendencies
- Massive pericardial, thoracic, or abdominal effusions
- Live attenuated vaccines within 4 weeks before cell infusion or planned during the study
- History of organ transplantation, stem cell transplantation, or renal replacement therapy
- Uncontrolled diabetes, lung or liver diseases
- Known alcohol or drug abuse
- Pregnant or breastfeeding women
- Any medical conditions that may impair study participation as judged by the researcher
- Lack of legal capacity or restricted capacity
- Previous gene or cell therapy product exposure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
Z
Zi B Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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