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RECRUITING
NCT07077512
PHASE2

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma

Official title: A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-15

Completion Date

2027-07-15

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

Autoleucel (Relmacabtagene Autoleucel)

Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).

DRUG

Sintilimab (PD-1 inhibitor)

Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.

Locations (3)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, China

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Guangzhou overseas Chinese hospital

Guangzhou, China