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Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
Sponsor: Sun Yat-sen University
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
Autoleucel (Relmacabtagene Autoleucel)
Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
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