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Multiple Myeloma (MM)Early Phase 1NCT07101705

An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed/Refractory Hematological Malignancies

A Early Phase 1 study testing OriV508 Injection in people with Multiple Myeloma (MM) and Non-Hodgkin Lymphoma (NHL), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
OriV508 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
8 Sep 2025to 1 Aug 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • 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 Organization (WHO) classification, the pathological types of aggressive B-NHL include: diffuse large B-cell lymphoma, not otherwise specified; diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements; high-grade B-cell lymphoma, not otherwise specified; primary mediastinal B-cell lymphoma; mantle cell lymphoma; grade 3b follicular lymphoma; large B-cell lymphoma transformed from indolent B-NHL.
  • For MM subjects 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 months after the last treatment; or be judged by the investigator as double-refractory to immunomodulators and proteasome inhibitors, and did not achieve a minimal response (MR) or better during the last treatment or experienced disease progression within 60 days after the end of treatment. (2) Have measurable lesions during the screening period, meeting any of the following criteria: (a) Serum M-protein ≥ 0.5 g/dL; (b) Urine M-protein≥ 200 mg/24h; (c) Involved free light chain (FLC) level ≥10 mg/dL provided serum FLC ratio is abnormal; (d) Plasma cell percentage ≥30% detected by bone marrow aspirate/biopsy; (e) Presence of at least one extramedullary lesion with a maximum diameter ≥ 2 cm.
  • For aggressive B-NHL subjects 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 progression after the end of treatment. Previous treatments must include standard treatment regimens with anti-CD20 monoclonal antibodies (except for subjects with CD20-negative tumors) and anthracyclines; (2) Have at least one measurable lesion during the screening period: lymph node lesions must have a longest diameter > 1.5 cm, and extranodal lesions must have a longest diameter > 1.0 cm.
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  • 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 whether to enroll based on clinical indications).
  • Liver function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × upper limit of normal (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%.
  • 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 willing to participate in the study.

Who cannot join

  • 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;
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  • 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 subjects 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 treated non-melanoma skin cancer with no evidence of active disease.
  • 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 of detachment, enrollment is permitted.
  • 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 with peripheral blood hepatitis C virus (HCV) RNA titer exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heng Mei, Ph.D&M.D contact

027-8572600

hmei@hust.edu.cn

Jia Xu, Ph.D contact

+86 18274201261

xu_jia@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Jia Xu, Ph.D, +86 18274201261, xu_jia@hust.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

This investigator-initiated clinical study aims to evaluate OriV506 injection, the self-inactivating lentiviral vector that carries a BCMA/CD19 dual-target CAR, in patients with relapsed refractory B-cell hematological malignancies. The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Being tested
OriV508 Injection
Keywords
BCMA/CD19, multiple myeloma, Non-Hodgkin lymphoma, In vivo CAR-T
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OriV508 InjectionDrug

    Also called OriV508

    OriV508 injection is one kind of non-replicative self-inactivating lentivirus vector which carries an effective BCMA/CD19 dual-target CAR. OriV508 can be administered intravenously and produce BCMA/CD19 CAR-T in vivo.

Study groups in NCT07101705
Study groupRoleWhat they receive
OriV508 injectionExperimentalOriV508 injection is one kind of non-replicative self-inactivating lentivirus vector which carries an effective BCMA/CD19 dual-target CAR. OriV508 can be administered intravenously and produce BCMA/CD19 CAR-T in vivo.
Receives: Drug: OriV508 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs)

    Measured: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.

  2. Cytokine release syndrome (CRS)

    Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus.

    Measured: up to Day 28 post-infusion

  3. Immune cell-associated immune effector cell-associated neurotoxicity syndrome (ICANS)

    ICANS would be scored according to Immune Effector Cell-Associated Encephalopathy (ICE), and then graded by the ASTCT consensus.

    Measured: up to Day 28 post-infusion

  4. Treatment-associated adverse effects (AEs)

    All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    Measured: From the enrollment to up to the end of treatment at 96 weeks after treatment of OriV508 or withdrawal from the study

Secondary outcomes (8)

  1. Overall response rate (ORR)

    Clinical efficacy of MM cohort can be evaluated according to the 2016 International Myeloma Working Group consensus criteria. ORR = stringent complete response (sCR) rate + complete response (CR) rate + very good partial response (VGPR) rate + partial response (PR) rate.

    Clinical efficacy of B-NHL cohort can be evaluated according to the Lugano 2014 criteria. ORR = CR+PR.

    Measured: From OriV508 infusion to the end of treatment at 96 weeks

  2. Complete response (CR) rate

    Clinical efficacy of MM cohort can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.Clinical efficacy of B-NHL cohort can be evaluated according to the Lugano 2014 criteria.

    Measured: From OriV508 infusion to the end of treatment at 96 weeks

  3. Duration of response (DOR)

    DOR is defined as the interval between the first sCR, CR, VGPR, or PR after infusion and the disease progression or death.

    Measured: From OriV508 infusion to the end of the treatment at 96 weeks

  4. Time to response (TTR)

    TTR is defined as the interval between the initiation of OriV508 treatment and the first assessment of sCR, CR, VGPR or PR.

    Measured: From OriV508 infusion to the end of treatment at 96 weeks

  5. Progression-free survival (PFS)

    PFS is defined as the interval between a subject's receipt of OriV508 infusion and the first assessment of disease progression or death.

    Measured: From OriV508 infusion to the end of the treatment at 96 weeks

  6. Overall survival (OS)

    OS is defined as the interval between a subject's receipt of OriV508 infusion and death from any cause.

    Measured: From OriV508 infusion to the end of treatment at 96 weeks

  7. Minimal residual disease (MRD) - negative assessment

    This outcome is primarily chosen for patients with multiple myeloma and aims to calculate the proportion of all patients achieving MRD negative status.

    Measured: From OriV508 infusion to the end of treatment at 96 weeks

  8. CAR-T kinetics

    CAR-T kinetics would be detected by flow cytometry and droplet digital or quantitative polymerase chain reaction in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells.

    Measured: Baseline, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 or withdrawal from the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start8 Sep 2025
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07101705
Sponsor's protocol ID
OriV508-T1
Status last verified
Jul 2026
First submitted
28 Jul 2025
Last updated
21 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing OriV508 Injection in people with Multiple Myeloma (MM) and Non-Hodgkin Lymphoma (NHL), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 19 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heng Mei, Ph.D&M.D (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: Dose-limiting toxicities (DLTs) are evaluated between the infusion and 28 days post-infusion.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07101705.

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 21 Jul 2026.

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