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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| relmacabtagene autoleucel and transplantation | Experimental | relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, with orelabrutinib, and sintilimab as maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relmacabtagene autoleucel and transplantation | Drug | This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 60 months |
| overall response rate(ORR) | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 60 months |
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Inclusion Criteria:
1.18-60 years 2.ECOG performance status 0-2 3.No prior treatment with CAR-T cell therapy or autologous stem cell transplantation (ASCT) 4.Expected survival ≥ 3 months 5.No history of malignancy (except for in situ carcinoma or other indolent malignancies), or inactive malignancy with treatment completed >1 year ago 6.Histopathologically confirmed PCNSL (lymphoma confined to the brain without systemic involvement, with histopathological type being diffuse large B-cell lymphoma, or systemic lymphoma with central nervous system involvement and histopathological type being diffuse large B-cell lymphoma) 7.Refractory disease is defined as failure to achieve complete remission after first-line therapy (excluding intolerance to first-line therapy), including: Progressive disease (PD) as best response to first-line therapy, or Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP), or Residual disease after at least 6 cycles of first-line therapy, or relapse within 12 months after completing first-line therapy 8.Relapsed disease is defined as recurrence after achieving complete remission following first-line therapy, occurring within 12 months after treatment completion 9.Positive CD19 expression by immunohistochemistry 10.No contraindications for CAR-T cell therapy or ASCT 11.No concurrent use of other anti-tumor therapies during this treatment; bisphosphonates for bone metastases and symptomatic supportive treatments are allowed 12.Able to understand the study and provide signed Informed Consent Form
Exclusion Criteria:
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|
| ID | Term |
|---|---|
| C000718412 | relmacabtagene autoleucel |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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