To evaluate the efficacy and safety of relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, orelabrutinib, and sintilimab as first-line or relapsed/refractory treatment for primary central nervous system diffuse large B-cell lymphoma.
None
Pregnant or lactating women
Any uncontrolled medical condition (including active infection, uncontrolled diabetes, severe cardiac, hepatic or renal insufficiency, interstitial pneumonia, etc.)
Use of systemic corticosteroids within 7 days before CD19 CAR-T cell infusion (except ≤ 5 mg/day dexamethasone or equivalent doses of other corticosteroids)
Prior exposure to ≥ 2 of the following agents with documented resistance: orelabrutinib, fotemustine, carmustine, thiotepa, or PD-1/PD-L1 inhibitors
Single group
Relmacabtagene autoleucel and transplantation
DrugThis study enrolled patients with primary central nervous system lymphoma, from whom mononuclear cells and hematopoietic stem cells were collected. Participants receive infusions of hematopoietic stem cells and CAR-T cells, followed by maintenance therapy with orelabrutinib and sintilimab starting on day 15 post-transplantation, for a median duration of up to 6 months and 1 year, respectively.
progression-free survival(PFS)
PFS is defined as the time from CAR-T infusion to the first occurrence of either disease progression or death from any cause, whichever comes first, regardless of whether study treatment has been discontinued prior to the PFS event.
overall response rate(ORR)
Overall Survival (OS)
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