Advanced Solid TumorEarly Phase 1NCT05271279
A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors
A Early Phase 1 study testing OVV-01 Injection+IBR900 Cell Injection in people with Advanced Solid Tumor and Relapsed/Refractory Lymphoma, run by Beijing Boren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Relapsed/Refractory Lymphoma
- What is being tested?
- OVV-01 Injection+IBR900 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2021to 29 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Serum creatinine≤1.5×ULN, or creatinine clearance ≥50 ml/min (calculated according to Cockcroft/Gault formula);
- Coagulation function
- For subjects not receiving anticoagulation therapy: international normalized ratio (INR)≤1.5×ULN, activated partial thromboplastin time (APTT)≤1.5×ULN
- For subjects receiving anticoagulation therapy: INR≤ 2-3×ULN, APTT≤ 2-3×ULN Female subjects of childbearing age who is negative in the pregnancy test within 14 days before inclusion. Female subjects of childbearing age and male subjects whose partners are females of childbearing age must agree to use at least one medically approved birth control (such as surgical sterilization, oral contraceptives, intrauterine devices, sexual desire control or barrier contraception in combination with spermicides, etc.);
- 11.The subjects should voluntarily participate in the study, sign the informed consent forms, have good compliance, and cooperate with the follow-up visits.
Who cannot join
- 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;
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- 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);
- traditional Chinese medicine with anti-tumor indications within 2 weeks before the first administration of the study drug;
- Subjects with cardiovascular disorders meet any of the following:
- Congestive heart failure with heart function ≥ New York Heart Association (NYHA) III;
- Severe arrhythmia requiring drug therapy;
- Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass, and stent within 6 months before the first administration;
- Left ventricular ejection fraction (LVEF)< 50%;
- Corrected QTc interval > 450 ms for male and> 470 ms for female, or risk factors for torsade de pointes ventricular tachycardia, such as clinically significant hypokalemia judged by the investigator, family history of long QT syndrome, or familial arrhythmia history (such as pre-excitation syndrome);
- Uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg with treatment with standardized antihypertensive drugs)
- Subjects with active autoimmune diseases or a history of autoimmune diseases but may be relapsed; but subjects with the following diseases are not excluded and can be further screened:
- Type 1 diabetes mellitus;
- Hypothyroidism (if only hormone replacement therapy can be used to control);
- Controlled celiac disease;
- Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia);
- Any other diseases that will not relapse without external triggers;
- Subjects with any diseases who need to use glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents for systemic treatment within 14 days before administration of the study drug, but is using or have used any of the following steroids can be included:
- Adrenaline replacement steroids (prednisone ≤10 mg/day or equivalent dose of similar drugs);
- Local, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption;
- Prophylactically short-term (≤7 days) use of corticosteroids (such as allergy to contrast agents) or for the treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by contact allergens);
- Subjects with psychiatric disorders, alcoholism, heavy smoking, drug use or drug abuse, etc.;
- Female subjects who are pregnant or breastfeeding, or who are expected to become pregnant during the study (from the screening visit until 180 days after administration) and male subjects who are expected to conceive their partners;
- Subjects whose adverse reactions of prior anti-tumor treatments have not yet recovered to CTCAE v5.0 Grade 1 (except for the alopecia);
- Subjects who have serious uncontrollable diseases or other conditions that may affect the treatment of this study and are not suitable to participate in this study as determined by the investigator.
- Other conditions not suitable for enrollment at investigators' decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Open-Label, Investigator-Initiated Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Oncolytic Virus Injection (OVV-01) in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors
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.
Read the detailed description
In this study, it is planned to enroll about 6-12 subjects with advanced solid tumors or relapsed/refractory lymphomas who have failed in the third-line or higher standard of care in about 1-3 study sites in China. A 2-dose gradient joint exploratory study using the traditional "3+3" mode is adopted in this study. If the high-dose group does not yet reach the MTD, the investigator and funder will decide whether to continue the dose escalation and whether to add a new dose group.
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.
- Conditions
- Advanced Solid Tumor, Relapsed/Refractory Lymphoma
- Being tested
- OVV-01 Injection+IBR900 Cell Injection
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVV-01 Injection+IBR900 Cell InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: OVV-01 Injection+IBR900 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
To evaluate the safety and tolerability of OVV-01 injection and IBR900 cell injection
Measured: 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
Measured: 24 weeks after initial administration
Secondary outcomes (8)
Objective response rate (ORR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Measured: Up to 1 year after administration
Progression-free survival (PFS)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Measured: Up to 1 year after administration
Overall survival (OS)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Measured: Up to 1 year after administration
Disease control rate (DCR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Measured: Up to 1 year after administration
Duration of overall response (DOR)
To evaluate the effectivity of OVV-01 injection and IBR900 cell injection
Measured: Up to 1 year after administration
Peak plasma concentration of OVV-01
Blood samples will be collected at specified time points to detect the concentration of OVV-01 in peripheral blood and to evaluate the PK parameters
Measured: 14 days after the last administration
Peak plasma concentration of IBR900 cells
Blood samples will be collected at specified time points to detect the concentration of IBR900 cells in peripheral blood and to evaluate the PK parameters
Measured: 16 days after initial administration
Plasma concentration of anti-VSV-G antibody and neutralizing antibody
To observe and evaluate the time, titer, and subject rate of antibody development after administration
Measured: 16 weeks after initial administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start24 Dec 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Why it stopped: Research and development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Hu, MD/PhD, Principal investigator, Beijing Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271279
- Sponsor's protocol ID
- BR20210414003
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Investigator-Initiated Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Oncolytic Virus Injection (OVV-01) in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05271279
- Acronym / sponsor ID
- BR20210414003
- Conditions
- Advanced Solid Tumor, Relapsed/Refractory Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research and development strategy adjustment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, it is planned to enroll about 6-12 subjects with advanced solid tumors or relapsed/refractory lymphomas who have failed in the third-line or higher standard of care in about 1-3 study sites in China. A 2-dose gradient joint exploratory study using the traditional "3+3" mode is adopted in this study. If the high-dose group does not yet reach the MTD, the investigator and funder will decide whether to continue the dose escalation and whether to add a new dose group.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVV-01 Injection+IBR900 Cell Injection | Experimental | Biological: OVV-01 Injection+IBR900 Cell InjectionOVV-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
Key exclusion criteria (38 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVV-01 Injection+IBR900 Cell Injection2 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. | Biological | OVV-01 Injection+IBR900 Cell Injection |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 7 weeks after initial administration
To evaluate the safety and tolerability of OVV-01 injection and IBR900 cell injection
Adverse events (AEs)
Time frame: 24 weeks after initial administration
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
8 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 1 year after administration
Progression-free survival (PFS)
Time frame: Up to 1 year after administration
Overall survival (OS)
Time frame: Up to 1 year after administration
Disease control rate (DCR)
Time frame: Up to 1 year after administration
Duration of overall response (DOR)
Time frame: Up to 1 year after administration
Peak plasma concentration of OVV-01
Time frame: 14 days after the last administration
Peak plasma concentration of IBR900 cells
Time frame: 16 days after initial administration
Plasma concentration of anti-VSV-G antibody and neutralizing antibody
Time frame: 16 weeks after initial administration
Results and safety
The study was stopped early (reason given: Research and development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Hu, MD/PhD principal investigator
Beijing Boren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OVV-01 Injection+IBR900 Cell Injection in people with Advanced Solid Tumor and Relapsed/Refractory Lymphoma, run by Beijing Boren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Research and development strategy adjustment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 7 weeks after initial administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.