KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
NCT ID: NCT06752473
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2025-01-31
2027-02-28
Brief Summary
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Detailed Description
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Approximately 120 mL of PBMCs is collected from subjects. The collected PBMCs are transported to the manufacturing facility for the preparation of KSD-101. Subjects return to the study site for subsequent visits at investigator-notified times.
1. KSD-101 route of administration: subcutaneous injection.
2. KSD-101 treatment dose: 5.0 × 10\^6 cells/dose.
3. KSD-101 treatment frequency: once every 2 weeks for a total of 3-5 times. The 4th and 5th times are booster treatments, which need to be decided by the investigator according to the condition of the subjects.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KSD-101
Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with EBV antigen.
KSD-101
Patients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
Interventions
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KSD-101
Patients will receive approximately 5x10\^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
Eligibility Criteria
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Inclusion Criteria
2. Female or emale 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. An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
7. Have criteria for single or venous blood collection and have no other contraindications to cell collection.
8. Patients' laboratory findings are compatible:
(1)Blood routine: neutrophils ≥ 1.5×10\^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100×10\^9/L.
(2)Liver function: ALT, AST ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN. (3)Renal function: creatinine ≤ 1.5 × ULN. (4)Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%. (5)Coagulation function: fibrinogen ≥ 1.0g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN.
9.Patients' corresponding lymph node region can accommodate subcutaneous injections.
10.Expected survival ≥ 3 months.
Exclusion Criteria
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. Patients have 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. Patients have received a prophylactic live or live attenuated vaccine within 4 weeks prior to screening.
10. Patients have 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. Patients have substance abuse/addiction. 13,Patients have other conditions that, in the judgment of the investigator, make enrollment inappropriate.
18 Years
70 Years
ALL
No
Sponsors
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Kousai Bio Co., Ltd.
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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KSD-101-CR005
Identifier Type: -
Identifier Source: org_study_id