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.
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.
For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.
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).
Single group
Allogeneic CAR-T
Biological/VaccinePatients will receive lymphodepletion chemotherapy followed by a single intravenous infusion of Allogeneic CAR-T cells. In select cases, CAR-T infusion may be administered post-autologous hematopoietic stem cell transplantation (auto-HSCT)
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria
Objective Response Rate (ORR)
Identify the number of patients with complete response (CR), Identify the number of patients with partial response (PR), and Calculate ORR=(CR+PR)/total patients
Disease control rate (DCR)
Identify the number of patients with complete response (CR), partial response (PR), stable disease (SD) and calculate DCR=(CR+PR+SD)/total patients
Progression-free survival (PFS)
PFS defned as the time from the date of RN1201 infusion to the frst assessment of confrmed disease progression or death
Overall survival (OS)
OS defned as the time from the date of RN1201 infusion to death
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This trial is not recruiting at the moment. You can still explore other options:
