RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
China27 participantsStarted 2025-08
Plain-language summary
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary participation with signed informed consent.
✓. Pathologically confirmed CD19-positive and/or B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.
✓. Relapsed/refractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.
. Known hypersensitivity, allergy, intolerance, or contraindication to CD19/BCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).
✕. Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.
✕. Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.
✕. NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).
✕. Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.
✕. Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.
✕. History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..