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
Relmacabtagene Autoleucel treatment: Patients will receive intravenous fludarabine (25 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days) for lymphodepletion, with adjustments based on hematologic and renal function.Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion. Sintilimab treatment: 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. Primary endpoint: The complete response rate (CRR) at 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
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.
Sun Yat-sen Universitiy Cancer Center
Guangzhou, China
RECRUITINGFifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
NOT_YET_RECRUITINGGuangzhou overseas Chinese hospital
Guangzhou, China
NOT_YET_RECRUITINGThe complete response rate (CRR) at 3 months
Time frame: Up to 3 months after Relmacabtagene Autoleucel infusion
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Time frame: Through study completion, an average of 2 years
Objective Response Rate
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 1 year after Relmacabtagene Autoleucel infusion
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