Clinical trial NCT05635591: KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial
Official title: KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: EBV-associated Haematologic Neoplasms
Keywords: EBV
haematologic neoplasms
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Kousai Bio Co., Ltd.
First posted: 2022-12-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

1. The patient or his legal guardian participated voluntarily and signed the informed consent form.
2. A patient aged 18 - 70 years ( inclusive ) on the day of signing the informed consent form, male or female.
3. 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.
4. ECOG performance score 0 - 1.
5. Meet apheresis or intravenous blood collection criteria and no other contraindications.
6. 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.
7. A patient who has a lymph node area where subcutaneous injection can be performed.

Exclusion Criteria:

1. A patient who has received any anticancer therapy such as chemotherapy, radiotherapy or immunotherapy (eg, immunosuppressive drugs) within one month prior to screening.
2. 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.
3. 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.
4. A patient who has central nervous system disorders (e.g., brain oedema, hormonal intervention indicated, or progression of brain metastases).
5. 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）
6. A patient who has serious underlying diseases (such as cardiovascular disease, respiratory disorder, renal insufficiency, coagulation disorder, autoimmune disease or immunodeficiency disease, etc.).
7. 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.
8. A patient who has received prophylactic live or live-attenuated vaccines within 4 weeks prior to screening
9. A patient who has participated in other clinical studies within 4 weeks prior to screening
10. A patient who has a prior history of serious drug allergy or penicillin allergy.
11. A patient who has a history of drug abuse/addiction.
12. A patient who has any conditions resulting in ineligibility for enrollment as judged by the investigator.

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT) by dose group
timeFrame: 1 years after DC Vaccines injection
measure: Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms
timeFrame: 1 years after DC Vaccines injection
measure: Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
timeFrame: 1 years after DC Vaccines injection
Secondary outcomes:
measure: EBV-DNA load
timeFrame: 1 years after DC Vaccines injection
measure: Objective response rate (ORR)
timeFrame: 1 years after DC Vaccines injection
measure: Disease control rate (DCR)
timeFrame: 1 years after DC Vaccines injection
measure: Duration of response (DOR)
timeFrame: 1 years after DC Vaccines injection
measure: Progression-free survival (PFS)
timeFrame: 1 years after DC Vaccines injection
measure: Overall survival (OS)
timeFrame: 1 years after DC Vaccines injection
measure: Levels of EBV-specific CD8+ T cells
timeFrame: 1 years after DC Vaccines injection
measure: Levels of B cells
timeFrame: 1 years after DC Vaccines injection
measure: Levels of NK cells
timeFrame: 1 years after DC Vaccines injection
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Li Chunrui
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Li Chunrui
role: PRINCIPAL_INVESTIGATOR
References: