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| No ID | Other Grant/Funding Number |
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This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.
R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T+ASCT | Experimental | R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7). A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year PFS rate | 1-year progression-free survival rate | From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| bORR | Best objective response rate | The best therapeutic effect within 12 months after CAR-T infusion was the proportion of subjects achieving complete remission (CR) or partial remission (PR). |
| DOR |
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Inclusion Criteria:
Age ≥ 18 years
Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)
Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
ECOG 0 to 2
Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy
Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL/min
Left ventricular ejection fraction (LVEF) ≥ 40%
Life expectancy ≥ 3 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Chen | Contact | +8617816890591 | zjuchenxi@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhengjiang | 310022 | China |
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| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
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Duration of response
| 12 months after CAR-T infusion |
| PFS | Progression-free survival | From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months |
| OS | Overall survival | From date of CAR-T infusion until the date of first documented date of death from any cause, assessed up to 12 months |
| AE and SAE | Any grade of AE and SAE | All adverse events that occurred from the time of enrollment to 12 months after the CAR-T infusion |