Nasopharyngeal Carcinoma (NPC)Early Phase 1NCT06752473
KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
A Early Phase 1 study testing KSD-101 in people with Nasopharyngeal Carcinoma (NPC) and EBV, run by Kousai Bio Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), EBV
- What is being tested?
- KSD-101
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2025to 28 Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
Show all 12Show fewer
- Have criteria for single or venous blood collection and have no other contraindications to cell collection.
- 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.
Who cannot join
- 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.).
Show all 12Show fewer
- 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. 13,Patients have other conditions that, in the judgment of the investigator, make enrollment inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
This is a single-center, single-arm, open, multiple-dose clinical study evaluating the safety, preliminary efficacy, and immune response of KSD-101 for the treatment of patients with EBV-associated nasopharyngeal carcinoma.
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.
- KSD-101 route of administration: subcutaneous injection.
- KSD-101 treatment dose: 5.0 × 10^6 cells/dose.
- 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
- Nasopharyngeal Carcinoma (NPC), EBV
- Being tested
- KSD-101
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSD-101Biological
Patients will receive approximately 5x10^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.
| Study group | Role | What they receive |
|---|---|---|
| KSD-101 | Experimental | Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with EBV antigen. Receives: Biological: KSD-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after DC Vaccines injection
Secondary outcomes (13)
EBV-DNA load
changes in EBV-DNA load were assessed during the study
Measured: 1 year after DC Vaccines injection
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Measured: 1 year after DC Vaccines injection
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Measured: 1 year after DC Vaccines injection
Duration of response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease
Measured: 1 year after DC Vaccines injection
Progression-free survival (PFS)
The time from the start of CAR-GPRC5D treatment for the participants to the first time of disease progression or death for any reason
Measured: 1 year after DC Vaccines injection
Overall survival (OS)
OS is measured from the date of the initial injection of DC Vaccines to the date of the participant's death
Measured: 1 year after DC Vaccines injection
Levels of EBV-specific CD8+ T cells
EBV-specific CD8+ T cells in peripheral blood will be assessed to monitor changes
Measured: 1 year after DC Vaccines injection
Levels of B cells
B cells in peripheral blood will be assessed to monitor changes
Measured: 1 year after DC Vaccines injection
Levels of NK cells
NK cells in peripheral blood will be assessed to monitor changes
Measured: 1 year after DC Vaccines injection
According to EORTC QLQ-C30
Changes of Quality of life, according to EORTC QLQ-C30
Measured: Up to 1 year
According to EQ-5D-5L
Changes of Quality of life, according to EQ-5D-5L
Measured: Up to 1 year
According to EORTC QLQ-H&N35
Changes of Quality of life, according to EORTC QLQ-H\&N35
Measured: Up to 1 year
According to ECOG fitness status
Changes of Quality of life, according to ECOG fitness status
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start31 Jan 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kousai Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752473
- Sponsor's protocol ID
- KSD-101-CR005
- Status last verified
- Nov 2024
- First submitted
- 27 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06752473
- Acronym / sponsor ID
- KSD-101-CR005
- Conditions
- Nasopharyngeal Carcinoma (NPC), EBV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kousai Bio Co., Ltd.University, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, single-arm, open, multiple-dose clinical study evaluating the safety, preliminary efficacy, and immune response of KSD-101 for the treatment of patients with EBV-associated nasopharyngeal carcinoma.
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.
- KSD-101 route of administration: subcutaneous injection.
- KSD-101 treatment dose: 5.0 × 10^6 cells/dose.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KSD-101 | Experimental | Biological: KSD-101Biological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with EBV antigen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSD-101Patients will receive approximately 5x10^6 DC vaccine via subcutaneous injections bi-weekly,total 3-5 times. | Biological | KSD-101 |
Primary outcome
The incidence Adverse events (Safety endpoint)
Time frame: 1 year after DC Vaccines injection
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.
13 secondary outcomes
EBV-DNA load
Time frame: 1 year after DC Vaccines injection
Objective response rate (ORR)
Time frame: 1 year after DC Vaccines injection
Disease control rate (DCR)
Time frame: 1 year after DC Vaccines injection
Duration of response (DOR)
Time frame: 1 year after DC Vaccines injection
Progression-free survival (PFS)
Time frame: 1 year after DC Vaccines injection
Overall survival (OS)
Time frame: 1 year after DC Vaccines injection
Levels of EBV-specific CD8+ T cells
Time frame: 1 year after DC Vaccines injection
Levels of B cells
Time frame: 1 year after DC Vaccines injection
Levels of NK cells
Time frame: 1 year after DC Vaccines injection
According to EORTC QLQ-C30
Time frame: Up to 1 year
According to EQ-5D-5L
Time frame: Up to 1 year
According to EORTC QLQ-H&N35
Time frame: Up to 1 year
According to ECOG fitness status
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
Related trials for Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KSD-101 in people with Nasopharyngeal Carcinoma (NPC) and EBV, run by Kousai Bio Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Hu (86-18930174575, xuri1104@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence Adverse events (Safety endpoint) (time frame: 1 year after DC Vaccines injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.