KSD-101 Therapy for Standard Treatment Failed EBV-associated NPC: an Exploratory Clinical Trial

NCT06370026 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: KSD-101-CR004
• 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)

• The incidence Adverse events (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.

  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 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 guardian voluntarily participate and sign an informed consent form.
• Female or emale 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 that has failed 3rd or more line treatment and has localized recurrence or localized recurrence with systemic metastasis or primary metastatic nasopharyngeal carcinoma that is not suitable for localized or radical treatment.
• At least one measurable lesion according to RECIST v1.1 criteria.
• An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
• Have criteria for single or venous blood collection and have no other contraindications to cell collection.
• Patients' laboratory findings are compatible:
• Blood routine: neutrophils ≥ 1.5×10\^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100×10\^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.
• Patients' corresponding lymph node region can accommodate subcutaneous injections.
• Expected survival ≥ 3 months.

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).
• Patients have 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.
• Patients have received a prophylactic live or live attenuated vaccine within 4 weeks prior to screening.
• Patients have participated in another clinical study within 4 weeks prior to screening.
• Patients with a prior history of severe drug allergy, or penicillin allergy.
• Patients have substance abuse/addiction.
• Patients have other conditions that, in the judgment of the investigator, make enrollment inappropriate.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kousai Bio Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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

• Fei Han

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Han

CONTACT

13822113698; hanfei@sysucc.org.cn

Yali Quan

CONTACT

15871707524; quanyali@kousai.vip

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)