A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors

NCT05271279 | Terminated Early Phase 1

• 1 other identifier: BR20210414003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, open-label, single-arm, investigator-initiated clinical trial to evaluate the safety and efficacy of oncolytic virus injection (OVV-01) in combination with trained immunity NK (tiNK) cell injection (IBR900) for patients with advanced malignant tumors.

Conditions

Advanced Solid Tumor; Relapsed/Refractory Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  To evaluate the safety and tolerability of OVV-01 injection and IBR900 cell injection

  7 weeks after initial administration

• Adverse events (AEs)

  The incidence and severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and the correlation between AEs and OVV-01 injection combined with IBR900 cell injection

  24 weeks after initial administration

Secondary Outcomes (8)

• Objective response rate (ORR)

  Up to 1 year after administration

• Progression-free survival (PFS)

  Up to 1 year after administration

• Overall survival (OS)

  Up to 1 year after administration

• Disease control rate (DCR)

  Up to 1 year after administration

• Duration of overall response (DOR)

  Up to 1 year after administration

Study Arms (1)

OVV-01 Injection+IBR900 Cell Injection

EXPERIMENTAL

OVV-01 injection combined with IBR900 cell injection, 2 dose gradients are used for the OVV-01 injection, and the total infusion dose of IBR900 cell injection is 4.0×10\^9 cells per cycle.

Biological: OVV-01 Injection+IBR900 Cell Injection

Interventions

OVV-01 Injection+IBR900 Cell Injection BIOLOGICAL

2 dose gradients are used for the OVV-01 injection, and the total infusion dose of IBR900 cell injection is 4.0×10\^9 cells per cycle. OVV-01 injection will be first administered at W1D1 and then at W4D1 followed by every 2 weeks as a treatment cycle, for a total of 6 doses; after the test in the high-dose group is completed, the investigator and sponsor will determine whether to adjust the dosing frequency of OVV-01 (such as once a week) based on the result evaluations. The IBR900 cell injection will be first administered at W1D3 and W1D5 for 2 infusions, and then at W4D3 and W4D5, followed by every 4 weeks as a cycle, for a total of 4 doses, and cell infusions will be conducted at W1, W4, W8 and W12, respectively.

OVV-01 Injection+IBR900 Cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are ≥18 years old and ≤75 years old, male or female;
• Subjects with advanced malignant tumors with the primary lesions and/or metastatic lesions diagnosed by histopathology/cytological examinations, including but not limited to: melanoma, the head and neck squamous cell carcinoma, cervical carcinoma, osteosarcoma, nasopharyngeal carcinoma, breast carcinoma, lung carcinoma, colorectal carcinoma, liver carcinoma, gastric carcinoma, lymphoma, etc.;
• Subjects with solid tumors or relapsed/refractory lymphomas who have failed in the third-line or higher standard of care;
• Subjects with at least one measurable lesion (non-lymph node lesion with longest diameter ≥10 mm, or lymph node lesion with short diameter ≥15 mm) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Evaluation Criteria for Efficacy of Lymphoma Lugano 2014;
• Subjects with the Eastern Cooperative Oncology Organization (ECOG) score of 0-2;
• Subjects with the expected survival ≥ 3 months;
• Subjects with adequate bone marrow function:
• White blood cell (WBC)≥3.0×10\^9/L;
• Neutrophils (ANC)≥1.5×10\^9/L (cannot use the colony stimulating factor within 3 days before the test);
• Lymphocyte count ≥6.0×10\^8/L;
• Platelet count ≥100×10\^9/L;
• Hemoglobin ≥9.0 g/dL;
• Subjects with adequate liver function and kidney function:
• Total bilirubin ≤1.5 times the upper limit of normal (ULN), or total bilirubin ≤3.0×ULN for subjects with liver metastases.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5×ULN, or AST and ALT≤5×ULN for subjects with liver metastases;

You may not qualify if:

• Subjects without measurable lesions;
• Subjects with symptomatic brain metastases (but subjects who have asymptomatic brain metastases or have been clinically stable for more than 3 months with local treatment can be included in the study);
• Subjects who have received radiotherapy for the target lesion within 2 months;
• Subjects with other active malignant tumors that require simultaneous treatment;
• Subjects who are known to be allergic to the study drug or its active ingredients and excipients;
• Subjects who have received or been receiving or still need to receive other investigational drug or antiviral treatments within 4 weeks before administration;
• Subjects who are going to undergo or have received tissue/organ transplantation;
• Subjects who have active infections or fever \>38.5°C of unknown cause during the screening phase and before the first dose;
• Subjects with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
• Subjects who are positive in the treponema pallidum serology test;
• Subjects with the medical history of known human immunodeficiency virus (HIV) positive or known acquired immunodeficiency syndrome (AIDS);
• Subjects with active hepatitis. Hepatitis B: HBeAg (+), HBcAb (+) in combination with+ HbsAg (+); for HBsAg (+) or HBcAb (+), the detection value of HBV DNA is ≥1000 IU/ml; hepatitis C: hepatitis C virus antibody (HCV Ab) positive and the detection value of HCV RNA is ≥1000 IU/ml; co-infection of hepatitis B and C;
• Subjects who have received anti-tumor drug therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, and immunotherapy within 4 weeks before the first administration except the following:
• nitrosourea or mitomycin C within 6 weeks before the first administration of the study drug;
• oral fluorouracil and small-molecular targeted drugs within 2 weeks before the first administration of the study drug or 5 half-lives of the drug (whichever is longer);

Sponsors & Collaborators

• Beijing Boren Hospital: lead

Study Sites (1)

Beijing Boren Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kai Hu, MD/PhD

  Beijing Boren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 9, 2022
• Study Start: December 24, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)