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NOT YET RECRUITING
NCT07113496
PHASE1

RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2025-08

Completion Date

2027-12

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic CAR-T

Patients 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)

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China