Tests allogeneic CAR-T cells in adults with relapsed or refractory B-cell blood cancers

Trial details

Who runs it

The First Affiliated Hospital with Nanjing Medical University

Trial code

NCT07113496

Record updated

13 August 2025

Original description

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.Read full original descriptionShow less

An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies

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.

Inclusion: 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; Measurable disease required:; For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission; For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria; For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease; Age ≥18 years; both sexes eligible; Expected survival ≥12 weeks; Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):; Total bilirubin <2× upper limit of normal (ULN); serum creatinine <ULN; ALT and AST <3× ULN; Absolute neutrophil count ≥0.5×10⁹/L; platelets ≥20×10⁹/L (no requirement if marrow involvement is documented); Eastern Cooperative Oncology Group (ECOG) performance status 0-3; Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion: 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; Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism); History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation; Any condition that, in the investigator's opinion, may increase risk or interfere with study results; Pregnancy, lactation, or planned pregnancy within 6 months.

ClinicalTrials.gov NCT07113496