OncoMatch/Clinical Trials/NCT07101705
An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies
Is NCT07101705 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies OriV508 for multiple myeloma (mm).
Treatment: OriV508 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
Previous treatments must include standard treatment regimens with anti-CD20 monoclonal antibodies (except for subjects with CD20-negative tumors)
Must have received: anthracycline
Previous treatments must include standard treatment regimens with...anthracyclines
Cannot have received: autologous hematopoietic stem cell transplantation
Received autologous hematopoietic stem cell transplantation within 24 weeks prior to signing the ICF
Cannot have received: allogeneic hematopoietic stem cell transplantation
Received organ transplantation or allogeneic hematopoietic stem cell transplantation
Cannot have received: small molecule targeted therapy
Small molecule targeted therapy...within 14 days or at least 5 half-lives, whichever is longer
Cannot have received: epigenetic therapy
epigenetic therapy...within 14 days or at least 5 half-lives, whichever is longer
Cannot have received: investigational drug
treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer
Cannot have received: immunosuppressive agent (tacrolimus, mycophenolate mofetil)
Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days
Cannot have received: monoclonal antibody
Monoclonal antibody treatment within 21 days
Cannot have received: cytotoxic chemotherapy
Cytotoxic therapy within 14 days
Cannot have received: proteasome inhibitor
Proteasome inhibitor therapy within 14 days
Cannot have received: immunomodulator
Immunomodulator agent therapy within 7 days
Cannot have received: corticosteroid (prednisone)
Exception: physiological replacement dose, topical and inhaled corticosteroids are permitted
Therapeutic dose of corticosteroids (defined as prednisone ≥ 20 mg/day or equivalent dose of other corticosteroids) within 72 hours
Cannot have received: radiation therapy
Exception: only for subjects whose radiation field covers > 5% of bone marrow reserve
Radiotherapy within 28 days (only for subjects whose radiation field covers > 5% of bone marrow reserve)
Cannot have received: viral therapy using vesicular stomatitis virus G (VSVG)-pseudotyped virus
Previously treated with any viral therapy using vesicular stomatitis virus G (VSVG)-pseudotyped virus
Lab requirements
Blood counts
Hemoglobin ≥ 6 g/dL (no RBC transfusion within 1 week prior to screening, recombinant human erythropoietin permitted); ANC ≥ 750 /μL (no G-CSF within 1 week or no pegylated G-CSF within 2 weeks prior to screening); Platelet count ≥ 50,000 /μL; Lymphocyte count ≥ 500 /μL
Kidney function
Creatinine clearance (CrCl) (MDRD formula) ≥ 40 mL/min/1.73m² (for MM subjects with CrCl < 40 mL/min/1.73m², investigator discretion)
Liver function
ALT and AST ≤ 3.0 × ULN, total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome or liver invasion by tumor, ALT and AST ≤ 5.0 × ULN and total bilirubin ≤ 3 × ULN are permitted)
Cardiac function
Left ventricular ejection fraction ≥ 45%
Hemogram meets the following requirements...Renal function...Liver function...Cardiac function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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