Actively Recruiting
An Open-label, Single-arm Study Evaluating Safety and Preliminary Efficacy of OriV508 Injection for Relapsed/Refractory Hematological Malignancies
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-09-09
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
O
OriCell Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, preliminary effectiveness, and immune response of OriV508 injection in patients with relapsed or refractory blood cancers, specifically multiple myeloma and aggressive B-cell non-Hodgkin lymphoma. This early phase 1, single-center, open-label study uses a dose escalation design to understand how this treatment works and its potential benefits. OriV508 is a lentiviral vector carrying a dual-target CAR that attacks BCMA and CD19 on cancer cells. OriV508 injection is given intravenously and works by producing BCMA/CD19 CAR-T cells inside the body. The study includes a dose escalation period to find safe and tolerable dosing levels. Participants receive the injection and are monitored closely for side effects and responses. The study duration extends up to 96 weeks for treatment and follow-up. Participants will have regular assessments including blood tests and evaluations for side effects such as dose-limiting toxicities, cytokine release syndrome, neurotoxicity, and other adverse events. Researchers will measure response rates, duration and time to response, survival outcomes, minimal residual disease status, and the behavior of CAR-T cells over time. Safety and effectiveness are monitored throughout the study and during the long-term follow-up period.
CONDITIONS
Brief Title
An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Confirmed diagnosis of multiple myeloma or aggressive B-cell non-Hodgkin lymphoma per specified criteria
- For multiple myeloma: received at least two prior anti-tumor therapies with disease progression or double-refractory status; measurable lesions present
- For aggressive B-cell NHL: received at least two prior therapies including anti-CD20 antibodies and anthracyclines; refractory or progressive disease; measurable lesions present
- Hemoglobin at least 6 g/dL without recent transfusion; adequate neutrophil, platelet, and lymphocyte counts
- Renal function with creatinine clearance of at least 40 mL/min/1.73m2 (investigator discretion allowed for lower)
- Liver function within specified limits
- Cardiac function with left ventricular ejection fraction of at least 45%
- Pulmonary function with pulse oxygen saturation of at least 92% without oxygen
- Negative pregnancy test for women of childbearing potential; agreement to use contraception and not donate reproductive cells during and for one year after treatment
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Recent use of investigational drugs, immunosuppressants, monoclonal antibodies, cytotoxic therapy, proteasome inhibitors, immunomodulators, corticosteroids, or radiotherapy within specified timeframes
- Autologous stem cell transplant within 24 weeks
- Organ or allogeneic stem cell transplantation
- Other active malignancies except treated skin cancer or tumors without active disease within 2 years
- Previous treatment with viral therapies using VSVG-pseudotyped virus
- Active central nervous system or meningeal involvement
- Severe uncontrolled infections
- Active autoimmune diseases requiring systemic immunosuppression
- Bleeding or coagulation disorders
- Active deep vein thrombosis or pulmonary embolism unless clinically resolved
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with elevated viral loads
- Severe cardiac diseases including advanced heart failure, recent heart attack or surgery, significant arrhythmias, or cardiomyopathy
- Other significant diseases such as primary immunodeficiency, recent stroke or seizures, dementia, Parkinson's disease
- Recent surgery within 2 weeks except local anesthesia
- Recent use of vaccines within 28 days
- Known severe allergies to OriV508, tocilizumab, or formulation components
- Inability to establish venous access
- Any other condition the investigator deems unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks after infusion
Participants receive OriV508 injection intravenously to produce BCMA/CD19 CAR-T cells in vivo. The study evaluates safety, tolerability, and preliminary efficacy during and after this treatment.
Multiple visits including baseline and frequent assessments up to 28 days post-infusion, then periodic visits up to 96 weeks
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
J
Jia Xu, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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