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EBV-associated Haematologic NeoplasmsPhase 1NCT05635591

KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial

A Phase 1 study testing Autologous monocyte - derived DCs pulsed with EBV antigen in people with EBV-associated Haematologic Neoplasms, run by Tongji Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The primary objectives of this study is to evaluate the tolerability and safety of KSD-101 in Patients with EBV-associated haematologic neoplasms, observe the dose-limiting toxicity (DLT) and and to explore the maximum tolerated dose (MTD). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
EBV-associated Haematologic Neoplasms
What is being tested?
Autologous monocyte - derived DCs pulsed with EBV antigen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
16 Jan 2023to 31 Dec 2026
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient or his legal guardian participated voluntarily and signed the informed consent form.
  • A patient aged 18 - 70 years ( inclusive ) on the day of signing the informed consent form, male or female.
  • A patient who is diagnosed with EBV - associated haematologic neoplasms，and fail to respond or relapse after conventional treatment, or voluntarily choose therapeutic DC vaccines as the salvage therapy.
  • ECOG performance score 0 - 1.
  • Meet apheresis or intravenous blood collection criteria and no other contraindications.
  • Adequate organ function:Hematology: neutrophils of ≥1×10^9 /L , hemoglobin of ≥ 70 g / L, platelets of ≥ 50 ×10^9 / L. Liver function: ALT, AST ≤ 3 × ULN and TBIL ≤ 1.5 × ULN.Renal function: creatinine ≤ 1.5 × ULN. Cardiac function: left ventricular ejection fraction LVEF ) ≥ 40%. Coagulation function: fibrinogen ≥ 1.0 g / L, activated partial thromboplastin time ( APTT ) ≤ 1.5 × ULN, prothrombin time ( PT ) ≤ 1.5 × ULN.
  • A patient who has a lymph node area where subcutaneous injection can be performed.

Who cannot join

  • A patient who has received any anticancer therapy such as chemotherapy, radiotherapy or immunotherapy (eg, immunosuppressive drugs) within one month prior to screening.
  • A female patient who is pregnant (positive urine/blood pregnancy test) or breastfeeding, or a male/female patient who plans to conceive in recent 1 year.
  • A patient who has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with positive titer of hepatitis B virus (HBV) DNA in peripheral blood; or has positive hepatitis C virus (HCV) antibody, hepatitis C virus (HCV) RNA in peripheral blood, human immunodeficiency virus (HIV) antibody, or syphilis.
  • A patient who has central nervous system disorders (e.g., brain oedema, hormonal intervention indicated, or progression of brain metastases).
  • Patients had an uncontrollable infectious disease within the first 4 weeks of enrollment（ except the CTCAE toxicity grade is less than 2 of genitourinary infections and upper respiratory tract infections , EBV infection）
  • A patient who has serious underlying diseases (such as cardiovascular disease, respiratory disorder, renal insufficiency, coagulation disorder, autoimmune disease or immunodeficiency disease, etc.).
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  • A patient who has had other active malignancies within the last 3 years, unless curable and clearly cured, such as basal or squamous cell carcinoma, carcinoma in situ of cervix or breast, etc.
  • A patient who has received prophylactic live or live-attenuated vaccines within 4 weeks prior to screening
  • A patient who has participated in other clinical studies within 4 weeks prior to screening
  • A patient who has a prior history of serious drug allergy or penicillin allergy.
  • A patient who has a history of drug abuse/addiction.
  • A patient who has any conditions resulting in ineligibility for enrollment as judged by the investigator.

Trial locations and contacts

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

China1 site

  • Li Chunrui

    Wuhan, Hubei, 430000

Other trials in China

About this study

The primary objectives of this study is to evaluate the tolerability and safety of KSD-101 in Patients with EBV-associated haematologic neoplasms, observe the dose-limiting toxicity (DLT) and and to explore the maximum tolerated dose (MTD).

Being tested
Autologous monocyte - derived DCs pulsed with EBV antigen
Keywords
EBV, haematologic neoplasms

What participants receive

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

  • Autologous monocyte - derived DCs pulsed with EBV antigenBiological

    Patients will receive approximately （5-10）x10^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.Doses 4 and 5 are designated as booster doses. The need for booster treatment and the exploration of alternative immunization schedules shall be determined by the Investigator based on the subject's condition.For subjects in the dose expansion phase, concomitant therapy recommended by the Investigator is permitted if the subject has a high tumor burden. In the event of disease progression, the Investigator is allowed to select an appropriate treatment regimen based on the subject's condition, while the subject may choose to continue receiving treatment KSD-101. If the subject declines to continue treatment KSD-101 but agrees to survival follow-up, they will be transitioned to the survival follow-up phase.

Study groups in NCT05635591
Study groupRoleWhat they receive
KSD-101ExperimentalNot described
Receives: Biological: Autologous monocyte - derived DCs pulsed with EBV antigen

What is being measured

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

  1. Incidence of dose-limiting toxicity (DLT) by dose group

    Dose limiting toxicity will be assessed after injection in each dose group

    Measured: 1 years after DC Vaccines injection

  2. Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms

    Maximally tolerated dose will be assessed after injection in each dose group

    Measured: 1 years after DC Vaccines injection

  3. Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group

    Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after injection, those related to study drug, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity.

    Measured: 1 years after DC Vaccines injection

Secondary outcomes (9)

  1. EBV-DNA load

    The load levels of EBV-DNA will be detected at each time point

    Measured: 1 years after DC Vaccines injection

  2. Objective response rate (ORR)

    The percentage of participants who achieved PR or better response

    Measured: 1 years after DC Vaccines injection

  3. Disease control rate (DCR)

    The percentage of participants who achieved SD or better response

    Measured: 1 years 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 years 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 years 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 years 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 years after DC Vaccines injection

  8. Levels of B cells

    B cells in peripheral blood will be assessed to monitor changes

    Measured: 1 years after DC Vaccines injection

  9. Levels of NK cells

    NK cells in peripheral blood will be assessed to monitor changes

    Measured: 1 years after DC Vaccines injection

Timeline

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

  1. First posted2 Dec 2022
  2. Study start16 Jan 2023
  3. Primary completion31 Dec 2026 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635591
Sponsor's protocol ID
KSD-101-CR001
Status last verified
Apr 2026
First submitted
14 Nov 2022
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous monocyte - derived DCs pulsed with EBV antigen in people with EBV-associated Haematologic Neoplasms, run by Tongji Hospital 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 7 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: enrolling by invitation, as of the sponsor's last update on 8 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 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?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (DLT) by dose group (time frame: 1 years after DC Vaccines injection). The study lists 3 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 NCT05635591.

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 8 Apr 2026.

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