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

NCT05882305 | Withdrawn Early Phase 1 DMC

• 1 other identifier: KSD-101-CR002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

EBV-associated Lymphomas

Outcome Measures

Primary Outcomes (3)

• Incidence of dose-limiting toxicity(DLT) by dose group

  Dose-limiting toxicity will be assessed after injection

  1 years after DC Vaccines injection

• Incidence of Effective dose range by dose grouphaematologic neoplasms

  Effective dose will be assessed after injection

  1 years after DC Vaccines injection

• 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.

  1 years after DC Vaccines injection

Secondary Outcomes (9)

• EBV-DNA load

  1 years after DC Vaccines injection

• Objective response rate(ORR)

  1 years after DC Vaccines injection

• Disease control rate(DCR)

  1 years after DC Vaccines injection

• Duration of response(DoR)

  1 years after DC Vaccines injection

• Progression-free survival(PFS)

  1 years after DC Vaccines injection

Study Arms (1)

KSD-101

EXPERIMENTAL

Biological: 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.

Biological: Autologous monocyte-derived DCs pulsed withEBV-associated antigen

Interventions

Autologous monocyte-derived DCs pulsed withEBV-associated antigen BIOLOGICAL

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

KSD-101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Kousai Bio Co., Ltd.: lead

Study Sites (1)

Changhai Hospital

Shanghai, China, 430000, China

Location

Study Officials

• Yang Jianmin

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: June 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)