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Tests treatment safety and results for Multiple Myeloma (MM)
Official title An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT07101705
What this study is testing
What is OriV508 Injection?
OriV508 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma (mm).
Also referred to as OriV508.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of OriV508 injection for patients with relapsed/refractory hematological malignancies.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18 - 75 years.
- ECOG scores 0-1.
- Expected survival time ≥ 12 weeks.
- Have a record of confirmed multiple myeloma (MM) according to IMWG criteria, or a record of histologically confirmed aggressive B-cell non-Hodgkin...
- For MM people only: (1) Have received at least 2 lines of anti-tumor therapy, with each line of therapy undergoing at least one complete treatment...
You likely can't join if
- The subject has received the following therapy prior to signing the ICF:
- Small molecule targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device...
- Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days;
- Monoclonal antibody treatment within 21 days;
- Cytotoxic therapy within 14 days;
- Proteasome inhibitor therapy within 14 days;
See the full eligibility criteria
Who can join
- Aged 18 - 75 years.
- ECOG scores 0-1.
- Expected survival time ≥ 12 weeks.
- Have a record of confirmed multiple myeloma (MM) according to IMWG criteria, or a record of histologically confirmed aggressive B-cell non-Hodgkin lymphoma (B-NHL). According to the definition of the 2022 World Health...
- For MM people only: (1) Have received at least 2 lines of anti-tumor therapy, with each line of therapy undergoing at least one complete treatment cycle, and have experienced disease progression during or within 12...
- For aggressive B-NHL people only: (1) Have received at least 2 lines of anti-tumor therapy, and are refractory to the last line of therapy (at least 2 cycles) (best response is PD or SD) or have experienced disease...
- Hemogram meets the following requirements:
- Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week prior to screening, recombinant human erythropoietin is permitted);
- Absolute neutrophil count (ANC) ≥ 750 /μL (no granulocyte colony-stimulating factor (G-CSF) used within 1 week prior to screening or no pegylated G-CSF used within 2 weeks prior to screening);
- Platelet count ≥ 50,000 /μL;
- Lymphocyte count ≥ 500 /μL.
- Renal function: Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease (MDRD) equation) ≥ 40 mL/min/1.73m2 (If the eGFR of an MM subject is \< 40 mL/min/1.73m2, the Investigator may decide...
- Liver function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN (for people with Gilbert's syndrome or liver invasion by tumor, ALT and AST ≤...
- Cardiac function: Left ventricular ejection fraction ≥ 45%.
- Pulmonary function: Pulse oxygen saturation ≥ 92% without oxygen inhalation.
- Women with childbearing potential must have a negative blood pregnancy test and not be in the lactation period.
- Men and women with childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent form (ICF) until 1 year after the investigational drug administration.
- Men and women with childbearing potential must agree not to donate reproductive cells such as sperm or eggs (oocytes) from the time of signing the ICF until 1 year after the investigational drug administration.
- The participant or their legally authorized representative agrees to participate in this clinical trial and signs the ICF, indicating that he/she understands the objective and procedures of this clinical trial and is...
What rules you out
- The subject has received the following therapy prior to signing the ICF:
- Small molecule targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer;
- Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days;
- Monoclonal antibody treatment within 21 days;
- Cytotoxic therapy within 14 days;
- Proteasome inhibitor therapy within 14 days;
- Immunomodulator agent therapy within 7 days;
- Therapeutic dose of corticosteroids (defined as prednisone ≥ 20 mg/day or equivalent dose of other corticosteroids) within 72 hours, but physiological replacement dose, topical and inhaled corticosteroids are permitted;
- Radiotherapy within 28 days (only for people whose radiation field covers \> 5% of bone marrow reserve).
- Received autologous hematopoietic stem cell transplantation within 24 weeks prior to signing the ICF.
- Received organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Have other malignant tumors prior to screening, except for the following cases: malignant tumors that have received radical treatment and have no known active disease within 2 years prior to screening; or adequately...
- Previously treated with any viral therapy using vesicular stomatitis virus G (VSVG)-pseudotyped virus.
- Known active central nervous system involvement or clinical signs of meningeal involvement.
- Complicated with severe uncontrolled active infections (bacterial, viral, fungal, etc.).
- Have active autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or diseases requiring systemic application of immunosuppressive drugs.
- Have hereditary bleeding/coagulation diseases, other diseases that may increase the risk of bleeding, etc.
- Have active deep vein thrombosis (cancer emboli or thrombus) or pulmonary embolism within 12 weeks prior to signing the ICF, but if the investigator judges that the thrombus has been clinically treated and has no risk...
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer exceeding the normal range; positive for hepatitis C virus (HCV) antibody...
- Complicated with symptomatic heart failure or other severe cardiac diseases such as arrhythmia:
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- Myocardial infarction, coronary artery bypass grafting (CABG) or coronary stent implantation within 24 weeks prior to signing the ICF;
- Clinically significant ventricular arrhythmia, or history of unexplained syncope (except those caused by vasovagal or dehydration);
- Significant non-ischemic cardiomyopathy history.
- Have other clinically significant diseases, including:
- Primary immunodeficiency;
- Stroke or epileptic seizure within 24 weeks prior to signing the ICF;
- Obvious clinical evidence of dementia or mental status changes;
- History of Parkinson's disease or Parkinson-like movement disorders.
- Underwent surgery within 2 weeks prior to signing the ICF or plan to undergo surgery within 2 weeks after drug administration, except for surgery under local anesthesia.
- Used attenuated/inactivated vaccines within 28 days prior to signing the ICF.
- Known severe allergic reaction to OriV508 or its formulation components.
- Known severe allergic reaction to tocilizumab.
- Inability to establish venous access.
- Other situations deemed unsuitable for participating in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.