Nasopharyngeal CarcinomaEarly Phase 1NCT06097793
KSD-101 Therapy for EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
A Early Phase 1 study testing KSD-101 in people with Nasopharyngeal Carcinoma, run by Kousai Bio Co., Ltd. at 1 site in China.
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 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
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).
- the patient has a serious underlying disease (cardiovascular disease, respiratory disease, renal insufficiency, coagulation abnormality, autoimmune disease or immunodeficiency disease, etc.).
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- 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.
- patients with other conditions that, in the judgment of the investigator, make them unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430030
Guangyuan Hu, +86 13886000095, h.g.y.121@163.com
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.
Enrolled subjects will receive a peripheral blood single nucleated cell collection (D-20) of approximately 120-150 ml. After the single collection is transported to the dendritic cell vaccine preparation party via the cold chain, a dendritic cell vaccine (KSD-101) will be prepared using the subject's own single nucleated cells. After successful preparation of KSD-101, the subject will return to the hospital for KSD-101 reinfusion as follows.
- 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
- Being tested
- KSD-101
- Keywords
- EBV, Nasopharyngeal Carcinoma
- 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 Multi-antigen). Receives: Biological: KSD-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after DC Vaccines injection
Secondary outcomes (13)
EBV-DNA load
Antiviral effect: 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 posted24 Oct 2023
- Study start4 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kousai Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangyuan Hu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097793
- Sponsor's protocol ID
- KSD-101-CR003
- Status last verified
- Mar 2024
- First submitted
- 16 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KSD-101 Therapy for EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06097793
- Acronym / sponsor ID
- KSD-101-CR003
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- EBV, Nasopharyngeal Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kousai Bio Co., Ltd.University, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
Enrolled subjects will receive a peripheral blood single nucleated cell collection (D-20) of approximately 120-150 ml. After the single collection is transported to the dendritic cell vaccine preparation party via the cold chain, a dendritic cell vaccine (KSD-101) will be prepared using the subject's own single nucleated cells. After successful preparation of KSD-101, the subject will return to the hospital for KSD-101 reinfusion as follows.
- 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 Multi-antigen). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 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
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. Monitor and assess the incidence and relevance to study drug and severity of all adverse events, vital signs, physical examination and laboratory findings.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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. This study is not recruiting at the moment.
Guangyuan Hu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KSD-101 in people with Nasopharyngeal Carcinoma, run by Kousai Bio Co., Ltd. at 1 site in China.
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 14 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangyuan Hu (+86 13886000095, h.g.y.121@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 12 Mar 2024.