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Relapsed or Refractory EBV-associated Hematological MalignanciesPhase 1NCT07532746

A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies

A Phase 1 study testing KSD-101 in people with Relapsed or Refractory EBV-associated Hematological Malignancies, run by Kousai Bio Co., Ltd. at 2 sites 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
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Trial summary

The main purpse of this study is to evaluate the safety and tolerability of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies,to preliminarily explore the clinical efficacy ,evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated… Read more about this study

Who is it for?
Ages 2 to 70 years
What is being tested?
KSD-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
1 May 2026to 31 Dec 2029
Phase
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 2 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects and/or their legal guardians agree to participate and sign the ICF.
  • Male or female subjects who are 2-70 (inclusive,If the age exceeds 70 years, the decision will be made jointly by the investigator and the sponsor.) years old.
  • Subjects with histologically and/or cytologically confirmed EBV-associated hematological diseases, including but not limited to EBV-positive diffuse large B-cell lymphoma, EBV-positive NK/T-cell lymphoma, EBV-positive Hodgkin's lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal T follicular helper (TFH) cell lymphoma (angioimmunoblastic-type), and EBV-positive primary cutaneous T-cell lymphoma, and meeting the following conditions
  • Positive for EBER by in situ hybridization (ISH or FISH) .
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1.
  • The EBV-associated lymphoma population must have at least one measurable lesion (lymph node lesion with a longest diameter > 15 mm, or extranodal lesion with a longest diameter > 10 mm).
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  • Eligible for leukapheresis and has no other contraindications for cell collection.
  • Must have adequate organ function (have not received blood transfusion or hematopoietic stimulating factor therapy within 28 days):
  • Hematology test: Monocyte count ≥ 0.1 × 10^9/L, neutrophil count ≥ 1.2 × 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 90 × 10^9/L
  • Liver function: ALT, AST ≤ 2.5 × ULN and TBIL ≤ 1.5 × ULN [for patients with liver metastases: ALT, AST ≤ 5 × ULN and TBIL≤ 2 × ULN]
  • Kidney function: Creatinine ≤ 1.5 × ULN (if creatinine > 1.5 ULN, creatinine clearance > 60 mL/mins is required) (The Cockcroft-Gault formula)
  • Pulmonary function: pulse oximetry ≥94%
  • Coagulation function: Fibrinogen ≥ 1.0 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% during the screening period
  • Male and female subjects of reproductive age agree to take non-pharmacological contraceptive measures from signing the ICF until 6 months after the last dose.

Who cannot join

  • Received chemotherapy or immunosuppressive therapy within 4 weeks prior to leukapheresis or radiotherapy within 2 weeks prior to leukapheresis.
  • Underwent allogeneic transplantation prior to enrollment.
  • Received (attenuated) live vaccines within 4 weeks prior to enrollment.
  • Participated in other clinical studies within 4 weeks prior to enrollment and received at least one dose of the investigational product.
  • Underwent therapeutic surgery within 4 weeks prior to enrollment, or plan to undergo major surgery during the study, except diagnostic, biopsy and drainage procedures.
  • Presence of uncontrolled infectious disease within 4 weeks prior to enrollment, except EBV infection.
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  • Receiving systemic corticosteroid therapy prior to screening and require long-term systemic corticosteroids during the treatment period (except inhalation or topical application) as judged by the investigator, or received systemic corticosteroid therapy (except inhalation or topical application) within 72 hours prior to administration.
  • Active central nervous system metastases/lesions (e.g., brain edema requiring hormone intervention or brain metastases).
  • Severe cardiovascular diseases:
  • Grade ≥ 3 cardiovascular diseases according to the New York Heart Association (NYHA) classification within 6 months prior to enrollment.
  • Unstable angina or severe arrhythmias requiring medication.
  • Other significant ECG abnormalities, including second-degree type 2 atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate < 50 beats/min with clinical symptoms), etc.
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and increased peripheral blood hepatitis B virus (HBV) DNA titer above the ULN; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis-specific antibodies.
  • Have not recovered to normal or Grade ≤ 1 from prior treatment-induced AEs prior to enrollment, except alopecia (any grade) and peripheral neuropathy (Grade ≤ 2).
  • Other active malignancies within the past 3 years, except for curable cancers that have been markedly cured, such as basal or squamous cell carcinoma, cervical or breast cancer in situ.
  • Prior history of severe drug allergies or history of penicillin allergy.
  • Substance abuse/addiction.
  • Women who are pregnant or nursing.
  • Other serious medical conditions, including liver disease, kidney disease, neurological/psychiatric disorders, endocrine disorders, hematologic disorders, and immune system disorders, which will render a subject unsuitable for participation in the study as judged by the investigator.
  • Other conditions that render a subject unsuitable for enrollment as judged by the investigator.

Trial locations and contacts

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

China2 sites

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, 021-64370045-610707

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Chunrui Li, +86 13647233185, cunrui5650@126.com

Other trials in China

About this study

Official title: A Single-arm, Open-label, Multi-center Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies

The main purpse of this study is to evaluate the safety and tolerability of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies,to preliminarily explore the clinical efficacy ,evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated hematological diseases and the improvement in subjects' quality of life (QOL) after KSD-101 treatment.

Read the detailed description

This is a multi-center, single-arm, open-label, dose confirmation and expansion Phase I clinical study to evaluate the safety, tolerability, immune response, and preliminary clinical efficacy of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies. The study is divided into three stages by age.

Being tested
KSD-101
Keywords
EBV, hematological malignancies
Medical subject headings
Recurrence, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KSD-101Biological

    Patients will receive DC vaccine via subcutaneous injections bi-weekly,total 3-5 times.

    KSD-101 treatment dose: The dose is tentatively set at 2.5 or 5.0 × 10^6 cells/dose in the adult cohort.

Study groups in NCT07532746
Study groupRoleWhat they receive
KSD-101ExperimentalBiological: Dendritic Cell Vaccine.Autologous monocyte-derived DCs pulsed with EBV-associated antigen.
Receives: Biological: KSD-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Incidence and number of dose-limiting toxicities.

    Measured: The duration from the first dose to Day 28

  2. adverse events (AEs)

    Adverse events will be graded according to the NCI-CTCAE 6.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guiding Principles for Grading Adverse Events in Vaccine Clinical Trials (Revised Edition).

    Measured: Any adverse medical event occurring from the initiation of leukapheresis until 28 days (±7 days) after the last dose, or initiation of a new treatment (whichever occurs first)

Secondary outcomes (9)

  1. EBV-DNA load

    Antiviral effect: changes in EBV-DNA load were assessed during the study

    Measured: The duration from the first dose to 48 weeks

  2. Objective response rate (ORR)

    The percentage of participants who achieved PR or better response

    Measured: The duration from the first dose to 48 weeks

  3. 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: The duration from the first dose to 48 weeks

  4. Disease control rate (DCR)

    The percentage of participants who achieved SD or better response

    Measured: The duration from the first dose to 48 weeks

  5. Progression-free survival (PFS)

    The time from the start of KSD-101 treatment for the participants to the first time of disease progression or death for any reason

    Measured: The duration from the first dose to 48 weeks

  6. Levels of EBV-specific CD8+ T cells

    EBV-specific CD8+ T cells in peripheral blood will be assessed to monitor changes

    Measured: The duration from the first dose to 48 weeks

  7. Levels of various lymphocyte subsets

    total T lymphocytes, activated T lymphocytes, helper T lymphocytes, cytotoxic T lymphocytes, regulatory T lymphocytes, total B lymphocytes and total NK cells in peripheral blood will be assessed to monitor changes

    Measured: The duration from the first dose to 48 weeks

  8. EQ-5D-5L

    The change from baseline in scores of EQ-5D-5L endpoints will be analyzed by age group or indication group.

    Measured: The duration from the first dose to 48 weeks

  9. QLQ-C30

    The change from baseline in scores of QLQ-C30 endpoints will be analyzed by age group or indication group

    Measured: The duration from the first dose to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532746
Sponsor's protocol ID
KSD-101-RT001
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KSD-101 in people with Relapsed or Refractory EBV-associated Hematological Malignancies, run by Kousai Bio Co., Ltd. at 2 sites 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 20 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: The duration from the first dose to Day 28). The study lists 2 primary outcomes in all. 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 NCT07532746.

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 16 Apr 2026.

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