CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

Launched by CORREGENE BIOTECHNOLOGY CO., LTD · Apr 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called CRTE7A2-01, is exploring a new treatment using specially engineered T cells for patients with advanced cancers that are positive for the HPV-16 virus, such as cervical cancer, anal cancer, and certain head and neck cancers. The main goal of this study is to find out if this new treatment is safe and how well it works for patients who have not responded to standard treatments. The trial is currently not recruiting participants, but it aims to include adults aged 65 and older who have advanced solid tumors that have not improved with previous therapies.

To be eligible for the trial, patients must have specific types of advanced cancers that have progressed despite receiving at least one or two previous treatments. They also need to have a certain genetic marker (HLA-A*02:01) and be able to provide a measurable tumor for assessment. Participants will receive injections of the new T cell treatment and will be monitored for safety and effectiveness. It’s important for potential participants to understand that they must meet strict health criteria and be willing to follow the study guidelines. This trial represents a hopeful option for patients facing limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Age \>18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard treatment confirmed by histology and/or cytology, or who are intolerant to such treatment, and for whom there is no effective therapy available after standard treatment failure are considered as end-stage patients. Specifically for:
• • 1. Cervical cancer: a) Patients who have previously failed at least second-line systemic therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and have shown disease progression or intolerance confirmed by pathological or radiological examination during or after the most recent treatment course, and are not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic cervical cancer.
• • 2. Nasopharyngeal cancer: a) Patients who have previously failed at least third-line systemic therapy or are intolerant, not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic nasopharyngeal cancer; b) EB virus negative.
• • 3. Head and neck squamous cell carcinoma: a) Patients who have previously failed at least second-line systemic therapy or are intolerant, with no standard treatment options currently available for recurrent or metastatic head and neck squamous cell carcinoma (non-nasal).
• • 3. Confirmation of HPV16 positive and HLA-A\*02:01 allele. 4. ECOG performance status of 0-1. 5. Estimated life expectancy ≥ 3 months. 6. Patients must have at least one measurable lesion defined by RECIST 1.1. 7. Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.
• • 8. The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.
• Exclusion Criteria:
• • 1. Patient received any genetically modified T cell therapy.
• • 2. Patient is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
• • 3. Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
• 4. Patients have any organ system function impairment as defined below:
• • leukocytes\<3.0 x 109/L
• • absolute neutrophil count \>1.5 x 109/L
• • hemoglobin\<90g/L
• • platelets \<100 x 1010/L
• • lymphocytes\<0.5 x 109/L
• • percentage of lymphocytes\<15%
• • creatinine\>1.5×ULN or creatinine clearance \<50mL/min
• • total bilirubin\>3×ULN; ALT/AST\>3×ULN (patients with liver metastasis,\>5×ULN)
• • INR\>1.5×ULN; APTT\>1.5×ULN
• • SpO2≤90%
• • 6. Patinets has serious medical conditions, disorders, and / or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.
• • 7. Patient has a severe cardiovascular disease with 6 months before screening, including, but are not limited to, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Heart failure NYHA grade Ⅲ or Ⅳ.
• • 8. Left Ventricular Ejection Fractions (LVEF) \<50%. 9. Patient has a known active brain metastases. 10. Patient has a known myelodysplastic syndrome (MDS) or lymphoma. 11. Patient has a known active autoimmune disease, including , but are not limited to, acquired or congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease.
• • 12. Patient has a known active Hepatitis B or Hepatitis C. 13. Patient has a history of Human Immunodeficiency Virus (HIV) . 14. Patient has a history of syphilis. 15. Pregnant or lactating women. 16. Patient has a known active mental and neurological diseases. 17. The principal investigator judged that it is not suitable to participate in this clinical study.