To hear about similar clinical trials, please enter your email below
Trial Title:
KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial
NCT ID:
NCT05635591
Condition:
EBV-associated Haematologic Neoplasms
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
EBV
haematologic neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous monocyte - derived DCs pulsed with EBV antigen
Description:
Patients will receive approximately （5-10）x10^6 DC vaccine via subcutaneous injections
bi-weekly,totally 3-5 times.
Arm group label:
KSD-101
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Li Chunrui
Address:
City:
Wuhan
Zip:
430000
Country:
China
Start date:
January 16, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Kousai Bio Co., Ltd.
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635591
