Actively Recruiting
An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating 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
151 weeks
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
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- ECOG performance status score of 0 or 1
- Expected survival time of at least 12 weeks
- Confirmed diagnosis of multiple myeloma (MM) per IMWG criteria or aggressive B-cell non-Hodgkin lymphoma (B-NHL) per 2022 WHO classification
- For MM: received at least 2 prior anti-tumor therapies with disease progression during or within 12 months after last treatment, or double-refractory to immunomodulators and proteasome inhibitors without minimal response or progressed within 60 days after last treatment
- For MM: have measurable lesions meeting specified laboratory or imaging criteria
- For aggressive B-NHL: received at least 2 prior anti-tumor therapies including anti-CD20 monoclonal antibodies (unless CD20-negative) and anthracyclines, refractory to last line or progressed after last treatment
- For aggressive B-NHL: have at least one measurable lesion meeting size criteria
- Hemogram requirements: hemoglobin >= 6 g/dL, ANC >= 750/μL, platelet count >= 50,000/μL, lymphocyte count >= 500/μL
- Renal function: creatinine clearance >= 40 mL/min/1.73m² (investigator may enroll MM subjects with lower clearance based on clinical indication)
- Liver function: ALT and AST <= 3x ULN, total bilirubin <= 1.5x ULN (with exceptions for Gilbert's syndrome or liver invasion)
- Cardiac function: left ventricular ejection fraction >= 45%
- Pulmonary function: pulse oxygen saturation >= 92% without oxygen
- Women of childbearing potential must have negative pregnancy test and not be lactating
- Men and women with childbearing potential must agree to effective contraception from consent until 1 year after drug administration
- Men and women with childbearing potential must agree not to donate reproductive cells from consent until 1 year after drug administration
- Participant or legal representative must understand study and sign informed consent form
You will not qualify if you...
- Received small molecule targeted therapy, epigenetic therapy, investigational drug/device within 14 days or 5 half-lives before consent
- Received immunosuppressive agents within 28 days before consent
- Received monoclonal antibody treatment within 21 days before consent
- Received cytotoxic therapy within 14 days before consent
- Received proteasome inhibitor therapy within 14 days before consent
- Received immunomodulator agent therapy within 7 days before consent
- Received therapeutic dose corticosteroids (prednisone >= 20 mg/day or equivalent) within 72 hours before consent, except physiological replacement, topical, or inhaled corticosteroids
- Received radiotherapy within 28 days if bone marrow reserve >5% involved
- Received autologous hematopoietic stem cell transplantation within 24 weeks before consent
- Received organ or allogeneic hematopoietic stem cell transplantation
- History of other malignant tumors unless treated with no active disease within 2 years
- Prior viral therapy with vesicular stomatitis virus G-pseudotyped virus
- Active CNS involvement or meningeal signs
- Severe uncontrolled active infections
- Active autoimmune diseases requiring systemic immunosuppressive drugs
- Hereditary bleeding/coagulation disorders or increased bleeding risk
- Active deep vein thrombosis or pulmonary embolism within 12 weeks unless clinically resolved
- Positive for hepatitis B or C with viral load above normal, HIV antibody positive, or positive syphilis test
- Severe cardiac diseases including NYHA class III/IV heart failure, recent myocardial infarction or coronary interventions, significant arrhythmia, or cardiomyopathy
- Clinically significant diseases such as primary immunodeficiency, recent stroke or seizures, dementia, Parkinson's disease
- Surgery within 2 weeks before consent or planned within 2 weeks after drug administration except local anesthesia
- Received attenuated/inactivated vaccines within 28 days before consent
- Known severe allergy to OriV508 or its components
- Known severe allergy to tocilizumab
- Inability to establish venous access
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jia Xu, Ph.D
CONTACT
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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