RN1201injection 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.

NCT Number	NCT07113496
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Relapsed or Refractory B-cell Hematologic Malignancies, B-cell Acute Lymphoblastic Leukemia (B-ALL), Multiple Myeloma (MM), Plasmablastic Lymphoma, Relapsed or Refractory CD19+/BCMA+ Hematologic Malignancies, Mature B-Cell Lymphoma
Enrollment	27 participants
Start Date	2025-08
Primary Completion	2027-08 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-13