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.
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.
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;
Single group
OriV508 Injection
DrugOriV508 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.
Dose-limiting toxicities (DLTs)
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus.
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.
Treatment-associated adverse effects (AEs)
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
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.
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.
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.
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.
Immunogenicity of OriV508 injection
Anti-drug antibody (ADA) would be detected by ELISA or FCM.
Replication competent lentivirus (RCL)
RCL refers to a lentivirus (usually genetically unmodified) that retains the ability to autonomously replicate and produce infectious viral particles in host cells.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Huazhong University of Science and Technology
Sponsor institution
OriCell Therapeutics Co., Ltd.
Collaborator
