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

NCT06097793 | Recruiting Early Phase 1 DMC

• 1 other identifier: KSD-101-CR003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinoma,to evaluate the initial clinical outcomes and evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma

Keywords

EBV; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety endpoint

  Adverse events will be graded according to the NCI-CTCAE 5.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guidelines for Grading Criteria for Adverse Events in Clinical Trials of Vaccines for Prophylaxis. Monitor and assess the incidence and relevance to study drug and severity of all adverse events, vital signs, physical examination and laboratory findings.

  1 year after DC Vaccines injection

Secondary Outcomes (13)

• EBV-DNA load

  1 year after DC Vaccines injection

• Objective response rate (ORR)

  1 year after DC Vaccines injection

• Disease control rate (DCR)

  1 year after DC Vaccines injection

• Duration of response (DOR)

  1 year after DC Vaccines injection

• Progression-free survival (PFS)

  1 year after DC Vaccines injection

Study Arms (1)

KSD-101

EXPERIMENTAL

Biological: Dendritic Cell Vaccine（Autologous monocyte-derived DCs pulsed with EBV Multi-antigen).

Biological: KSD-101

Interventions

KSD-101 BIOLOGICAL

Patients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.

KSD-101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their legal guardians voluntarily participate and sign the informed consent form.
• male or female patients aged 18-70 years (inclusive of the cut-off value) on the date of signing the informed consent.
• Nasopharyngeal carcinoma confirmed by pathological tissue examination and EBER-positive in tumor tissue by in situ hybridization (ISH or FISH).
• 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.
• at least one measurable lesion according to RECIST v1.1 criteria.
• have an Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• have criteria for single or venous blood collection and have no other contraindications to cell collection.
• 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.
• The patient's corresponding lymph node region can meet the demand for subcutaneous injection.

You may not qualify if:

• Patients receiving any anti-tumor therapy such as chemotherapy, radiotherapy, immunosuppressive therapy, etc. within 4 weeks prior to mono-collection.
• Women who are pregnant (positive urine/blood pregnancy test), breastfeeding, or men or women who are planning to conceive within the last 1 year.
• 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.
• patients with central nervous system pathology (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases).
• 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).
• the patient has a serious underlying disease (cardiovascular disease, respiratory disease, renal insufficiency, coagulation abnormality, autoimmune disease or immunodeficiency disease, etc.).
• 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.
• 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.
• the patient has received a prophylactic live or live attenuated vaccine within 4 weeks prior to screening.
• the patient has participated in another clinical study within 4 weeks prior to screening.
• patients with a prior history of severe drug allergy, or penicillin allergy.
• the patient has substance abuse/addiction.

Sponsors & Collaborators

• Kousai Bio Co., Ltd.: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Guangyuan Hu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangyuan Hu

CONTACT

+86 13886000095; h.g.y.121@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: December 4, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)