This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed cytogenetically high-risk multiple myeloma who are ineligible or unwilling to undergo autologous stem cell transplantation (ASCT). Patients will receive lymphodepletion followed by a single infusion of RN1201 across four dose levels. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
Is willing and able to provide a written informed consent form before any trial-related activities are performed.
Must have a diagnosis of Multiple Myeloma (MM) according to the World Health Organization (WHO) 2017 revised criteria.
Must be diagnosed with active MM according to the International Multiple Myeloma Working Group (IMWG) criteria.
Must have a documented MM type that is B-cell maturation antigen (BCMA) positive and/or CD19 positive, confirmed at screening or from prior medical records.
Known history of allergic reaction, hypersensitivity, intolerance, or contraindication to the BCMA/CD19 allogeneic CAR-T product or any of its excipients, including fludarabine, cyclophosphamide, and tocilizumab.
Diagnosis of plasma cell leukemia.
Presence of non-paraskeletal extramedullary disease.
Relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with active graft-versus-host disease (GVHD) that requires treatment with steroids or immunosuppressive agents.
Single group
BCMA/CD19-targeted allogeneic CAR-T
DrugLymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
The incidence and severity of dose-limiting toxicities (DLTs)
The incidence and severity of treatment-emergent adverse events (TEAEs)
Overall effectiveness and duration of efficacy
Overall response rate (ORR) and complete response rate (CR), negative rate of MRD (detected by flow cytometry or NGS)
Pharmacokinetic (PK) of RN1201
Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow
Levels of Peripheral blood M protein
Levels of Peripheral blood M protein
Levels of urine M protein
Levels of urine M protein
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Allorunning Therapeutics
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
