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Nasopharyngeal CarcinomaEarly Phase 1NCT06370026

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

A Early Phase 1 study testing KSD-101 in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 May 2024to 31 Dec 2026
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
  • Healthy volunteers accepted
  • 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 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.
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  • 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.

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.).
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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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei Han contact

13822113698 ext. 86

hanfei@sysucc.org.cn

Yali Quan contact

15871707524 ext. 86

quanyali@kousai.vip

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial

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.

  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.
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 groups in NCT06370026
Study groupRoleWhat they receive
KSD-101ExperimentalBiological: 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.

  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.

    Measured: 1 year after DC Vaccines injection

Secondary outcomes (13)

  1. EBV-DNA load

    changes in EBV-DNA load were assessed during the study

    Measured: 1 year after DC Vaccines injection

  2. Objective response rate (ORR)

    The percentage of participants who achieved PR or better response

    Measured: 1 year after DC Vaccines injection

  3. Disease control rate (DCR)

    The percentage of participants who achieved SD or better response

    Measured: 1 year after DC Vaccines injection

  4. 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

  5. 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

  6. 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

  7. 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

  8. Levels of B cells

    B cells in peripheral blood will be assessed to monitor changes

    Measured: 1 year after DC Vaccines injection

  9. Levels of NK cells

    NK cells in peripheral blood will be assessed to monitor changes

    Measured: 1 year after DC Vaccines injection

  10. According to EORTC QLQ-C30

    Changes of Quality of life, according to EORTC QLQ-C30

    Measured: Up to 1 year

  11. According to EQ-5D-5L

    Changes of Quality of life, according to EQ-5D-5L

    Measured: Up to 1 year

  12. According to EORTC QLQ-H&N35

    Changes of Quality of life, according to EORTC QLQ-H\&N35

    Measured: Up to 1 year

  13. 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.

  1. First posted17 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370026
Sponsor's protocol ID
KSD-101-CR004
Status last verified
Apr 2024
First submitted
14 Apr 2024
Last updated
2 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 Sun Yat-sen University 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 15 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: opening soon, as of the sponsor's last update on 2 May 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?

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 Fei Han (13822113698 ext. 86, hanfei@sysucc.org.cn), 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?

On the ClinicalTrials.gov record for NCT06370026.

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 2 May 2024.

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