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EBV-associated LymphomasEarly Phase 1NCT05882305

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

A Early Phase 1 study testing Autologous monocyte-derived DCs pulsed withEBV-associated antigen in people with EBV-associated Lymphomas, run by Kousai Bio Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to determine the tolerability and feasibility of KSD-101 in patients with EBV-associated haematologic neoplasms,to observe the characteristics of dose-limiting toxicity (DLT)and to explore the range of effective dose. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
EBV-associated Lymphomas
What is being tested?
Autologous monocyte-derived DCs pulsed withEBV-associated antigen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
10 Jun 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
  • 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 Lymphomas，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.

China1 site

  • Changhai Hospital

    Shanghai, China, 430000

Other trials in China

About this study

The main purpose of this study is to determine the tolerability and feasibility of KSD-101 in patients with EBV-associated haematologic neoplasms,to observe the characteristics of dose-limiting toxicity (DLT)and to explore the range of effective dose.

Being tested
Autologous monocyte-derived DCs pulsed withEBV-associated antigen

What participants receive

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

  • Autologous monocyte-derived DCs pulsed withEBV-associated antigenBiological

    Patients will receive approximately （2.5-10）x10^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.

Study groups in NCT05882305
Study groupRoleWhat they receive
KSD-101ExperimentalBiological: Dendritic Cell Vaccine( (Autologous monocyte-derived DCs pulsed withEBV-associated antigen) Patients will receive approximately （2.5-10）x10^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.
Receives: Biological: Autologous monocyte-derived DCs pulsed withEBV-associated 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

    Measured: 1 years after DC Vaccines injection

  2. Incidence of Effective dose range by dose grouphaematologic neoplasms

    Effective dose will be assessed after injection

    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 events(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 posted31 May 2023
  2. Study start10 Jun 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Why it stopped: No Participants Enrolled

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882305
Sponsor's protocol ID
KSD-101-CR002
Status last verified
Oct 2024
First submitted
21 May 2023
Last updated
30 Oct 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 Autologous monocyte-derived DCs pulsed withEBV-associated antigen in people with EBV-associated Lymphomas, 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 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: withdrawn, as of the sponsor's last update on 30 Oct 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?

The study was withdrawn before enrolling participants, so there are no results.

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 NCT05882305.

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 Oct 2024.

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