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KSD-101 Therapy for EBV-associated Lymphomas: an Exploratory Clinical Trial | Clinical Trials | Clareo Health

WITHDRAWNEARLY_PHASE1

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

NCT05882305•Kousai Bio Co., Ltd.

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 Lymphomas，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.
+2 more criteria

Locations (1)

Changhai Hospital

Shanghai, China, China

Key Dates

Start Date

June 10, 2023

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2025

Last Updated

October 30, 2024

Conditions

EBV-associated Lymphomas

Interventions

Autologous monocyte-derived DCs pulsed withEBV-associated antigen

BIOLOGICAL