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

NCT ID: NCT05635591

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2025-06-30

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).

Conditions

EBV-associated Haematologic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KSD-101

Group Type: EXPERIMENTAL

Autologous monocyte - derived DCs pulsed with EBV antigen

Intervention Type: BIOLOGICAL

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

Interventions

Autologous monocyte - derived DCs pulsed with EBV antigen

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kousai Bio Co., Ltd.

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chunrui Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Chunrui

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Li Chunrui

Wuhan, Hubei, China

Countries

China

Other Identifiers

KSD-101-CR001

Identifier Type: -

Identifier Source: org_study_id