NCT07506668

RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas

An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19/CD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and/or CD20-positive cells in patients with relapsed/refractory B-cell lymphoma.

Conditions

• Relapsed/Refractory B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	RN1701 injection	RN1701 injection is a bispecific CD19/CD20-targeted allogeneic CAR-T. A single infusion of CAR-T cells will be administered intravenously

Timeline

• Start date: 2026-03-23
• Primary completion: 2028-03-30
• Completion: 2028-05-30
• First posted: 2026-04-02
• Last updated: 2026-04-02