Safety and Efficacy Study of Virus Activated Killer Immune Cells (VAK) for Malignant Pleural and Peritoneal Effusion

NCT05565014 | Unknown Early Phase 1

• 1 other identifier: HBCHC03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Theory of VAK：

1. 1.Immune cells (T cells for example) of cancer subjects may be domesticated by the tumor microenvironment, and have low efficacy to kill cancer cells. They could be restimulated by virus antigen, and play a powerful tumor killing role while intrapleural to subjects.
2. 2.Releasing of tumor-associated antigen could induce specific anti-tumor immune response.
3. 3.Separate the immune cells and tumor cells from Malignant Pleural and Peritoneal Effusion.
4. 4.Incubate the immune cells with inactivated viruses and tumor cells.
5. 5.Wash to remove impurities.
6. 6.Intrapleural the immune cells to patients

Conditions

Malignant Pleural Effusion; Malignant Peritoneal Effusion

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs and SAEs

  Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  28 days after the last treatment.

Secondary Outcomes (3)

• ORR of Malignant Pleural and Peritoneal Effusion by WHO 1997

  28 days after the last treatment.

• Progression Free Survival

  up to 1 year.

• Overall Survival

  up to 2 year.

Study Arms (2)

Virus Activated Killer immune Cells（VAK）

EXPERIMENTAL

The VAK should be given once a week, three times a circle. The VAK could given 1 or 2 circle for each subject. The dosage of Pleural Effusion（more than 10\^5/kg cells in 30-50mL solvent） differs from Peritoneal Effusion（more than 10\^4/kg cells in 30-50mL solvent）

Drug: Virus Activated Killer immune Cells

saline

PLACEBO COMPARATOR

50ml of saline was injected once a week,three times a circle.The saline could given 1 or 2 circle for each subject.

Drug: Saline

Interventions

Virus Activated Killer immune Cells DRUG

The VAK made from Pleural Effusion should be given to treat Malignant Pleural Effusion.The VAK made from Peritoneal Effusion should be given to treat Malignant Peritoneal Effusion.

Also known as: VAK

Virus Activated Killer immune Cells（VAK）

Saline DRUG

The use of saline was the same as VAK group.

saline

Eligibility Criteria

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

You may qualify if:

• Willing to sign informed consent;
• Pathological confirmed advanced malignant tumor with malignant pleural or peritoneal effusion;
• Vital signs stable, Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
• Age ≥ 18 years old, gender unlimited;
• Expected survival period more than 3 months;
• Subjects agree to take effective contraceptive measures at the time of enrollment and within 4 months after enrollment. The pregnancy test of female patients must be negative;
• Sufficient bone marrow, liver and kidney functions. Laboratory tests within 7 days before the first drug use meet the following requirements:
• Coagulation function: APTT ≤ 1.5 × ULN, while INR or PT ≤ 1.5 × ULN (not receiving anticoagulant therapy); ② Blood routine examination: Hgb ≥ 80g / L, WBC \> 3 × 10\^9/L、NEU≥1.0 × 10\^9/L、PLT≥80 × 10\^9/L;
• Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); AST and alt ≤ 2.5 times ULN (if abnormal liver function is mainly caused by tumor infiltration, it can be ≤ 5 times ULN; alkaline phosphatase ≤ 2.5 times ULN; ④ Renal function: bun and Cr ≤ 1.5 times ULN, creatinine clearance ≥ 40ml / min (calculated by Cockcroft Gault formula).

You may not qualify if:

• Subjects requiring emergency treatment due to intestinal obstruction or vascular compression;
• Subjects with active hemolytic anemia;
• Subjects with active central nervous system metastases were excluded, except those with brain metastases or asymptomatic cancer cells found in cerebrospinal fluid;
• Pregnant or lactating female;
• Systemic active infection, serious coagulation disorder or serious heart, respiratory and immune system diseases;
• Congenital or acquired immune function defects (such as HIV infection), hepatitis B infection (HBV-DNA ≥ 10 \^ 4 / ml), hepatitis C infection (HCV antibody and HCV RNA positive);
• Subjects who had serious infection within 4 weeks before the first medication were excluded, including but not limited to infectious complications, bacteremia and severe pneumonia requiring hospitalization;
• Subjects with active autoimmune diseases or a history of autoimmune diseases that may recur, but the following are not excluded:
• Type 1 diabetes
• Hypothyroidism (if controlled by hormone replacement therapy only)
• Controlled celiac disease ④ Skin diseases without systemic treatment (such as vitiligo, psoriasis, alopecia) ⑤ Any other disease that does not recur without external triggers.
• Those who had severe hypersensitivity to the drugs used in this protocol in the past;
• Subjects who are ready for or have previously received tissue / organ transplantation;
• Subjects with large pericardial effusion were excluded;
• Exclude those who have suffered from other malignant tumors within 2 years, except for cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, skin basal cell carcinoma, skin squamous cell carcinoma, thyroid papillary carcinoma and breast ductal carcinoma in situ that have been effectively removed;

Sponsors & Collaborators

• Sheng Hu: lead
• Binhui Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Sheng Hu, MD

CONTACT

15377602179; ehusmn@163.com

Shuang Dong, UK

CONTACT

15802766720; dongshuang_2008@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: July 24, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)