KSD-101 therapy for EBV-related nasopharyngeal cancer

KSD-101 Therapy for EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial

This study is testing a new vaccine made from patients' own immune cells to see if it can help people with EBV-related nasopharyngeal cancer.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Kousai Bio Co., Ltd. (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan)
• Trial ID: NCT06097793 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and preliminary efficacy of KSD-101, a dendritic cell vaccine, in patients with EBV-associated nasopharyngeal carcinoma. Participants will undergo a blood collection to prepare the vaccine using their own immune cells, followed by subcutaneous reinfusion of KSD-101 every two weeks for up to five doses. The study aims to assess the immune response generated by the treatment and its potential clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with confirmed EBV-positive nasopharyngeal carcinoma and measurable lesions.

Not a fit: Patients with nasopharyngeal carcinoma that is not EBV-associated or those who are not suitable for cell collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with EBV-associated nasopharyngeal carcinoma who have limited effective treatments available.

How similar studies have performed: While this approach is innovative, similar studies using dendritic cell vaccines have shown promise in other cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients or their legal guardians voluntarily participate and sign the informed consent form.
2. male or female patients aged 18-70 years (inclusive of the cut-off value) on the date of signing the informed consent.
3. Nasopharyngeal carcinoma confirmed by pathological tissue examination and EBER-positive in tumor tissue by in situ hybridization (ISH or FISH).
4. nasopharyngeal carcinoma with localized recurrence or localized recurrence with systemic metastasis, or primary metastatic nasopharyngeal carcinoma unsuitable for localized or radical treatment, for which there is no effective treatment and which is seriously life-threatening.
5. at least one measurable lesion according to RECIST v1.1 criteria.
6. have an Eastern Cooperative Oncology Group (ECOG) score: 0-1.
7. have criteria for single or venous blood collection and have no other contraindications to cell collection.
8. the patient's laboratory findings are compatible:

   * Blood routine: neutrophils ≥ 1.0×10\^9/L, hemoglobin ≥ 80g/L, platelets ≥ 50×10\^9/L.
   * Liver function: ALT, AST ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN.
   * Renal function: creatinine ≤ 1.5 × ULN.
   * Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%.
   * Coagulation function: fibrinogen ≥ 1.0g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN.
9. The patient's corresponding lymph node region can meet the demand for subcutaneous injection.

Exclusion Criteria:

1. Patients receiving any anti-tumor therapy such as chemotherapy, radiotherapy, immunosuppressive therapy, etc. within 4 weeks prior to mono-collection.
2. Women who are pregnant (positive urine/blood pregnancy test), breastfeeding, or men or women who are planning to conceive within the last 1 year.
3. active hepatitis B (HbsAg or HbcAb positive and HBV DNA ≥100 IU/mL), active hepatitis C (HCV antibody positive and peripheral blood HCV RNA positive); human immunodeficiency virus (HIV) antibody positive; syphilis test positive.
4. patients with central nervous system pathology (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases).
5. patients with uncontrollable infectious disease within 4 weeks prior to enrollment, or with active tuberculosis or on anti-tuberculosis therapy. (\< CTCAE grade 2 genitourinary infections and upper respiratory tract infections, except EBV infections).
6. the patient has a serious underlying disease (cardiovascular disease, respiratory disease, renal insufficiency, coagulation abnormality, autoimmune disease or immunodeficiency disease, etc.).
7. other active malignant tumors within the past 3 years, unless they are curable tumors and have been significantly cured, such as basal or squamous cell carcinoma, carcinoma in situ of the uterine cervix or breast.
8. subjects who have undergone major surgery or severe trauma within 4 weeks prior to enrollment or are expected to require major surgical intervention (i.e., surgery requiring the assistance of endotracheal anesthesia) during the study period.
9. the patient has received a prophylactic live or live attenuated vaccine within 4 weeks prior to screening.
10. the patient has participated in another clinical study within 4 weeks prior to screening.
11. patients with a prior history of severe drug allergy, or penicillin allergy.
12. the patient has substance abuse/addiction.
13. patients with other conditions that, in the judgment of the investigator, make them unsuitable for inclusion.

Where this trial is running

Wuhan

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (RECRUITING)

Study contacts

• Principal investigator: Guangyuan Hu — Tongji Hospital
• Study coordinator: Guangyuan Hu

Conditions: Nasopharyngeal Carcinoma, EBV