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| Name | Class |
|---|---|
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
| Guangzhou Overseas Chinese Hospital,Guangdong | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relmacabtagene Autoleucel in combination with Sintilimab | Experimental | Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoleucel (Relmacabtagene Autoleucel) | Drug | Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The complete response rate (CRR) at 3 months | Up to 3 months after Relmacabtagene Autoleucel infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | To investigate the preliminary anti-tumor efficacy | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigating Immune Microenvironment, Proteomic, and Metabolomic Changes Associated with Treatment Efficacy Across Different Patient Group | To investigate the immune microenvironment changes, along with proteomic and metabolomic alterations, and correlate these variations with treatment efficacy across different patient groups. | Through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD | Contact | 02087342823 | caiqq@sysucc.org.cn | |
| Yi Xia, MD. PhD | Contact | 02087342823 | xiayi@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center | Recruiting | Guangzhou | 51000 | China |
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| Sintilimab (PD-1 inhibitor) | Drug | 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. |
|
|
To investigate the preliminary anti-tumor efficacy |
| 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 | 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 | Through study completion, an average of 2 years |
| Objective Response Rate | To investigate the preliminary anti-tumor efficacy | Up to 1 year after Relmacabtagene Autoleucel infusion |
| Fifth Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | 510060 | China |
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| Guangzhou overseas Chinese hospital | Not yet recruiting | Guangzhou | 510632 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718412 | relmacabtagene autoleucel |
| D013812 | Therapeutics |
| C000632826 | sintilimab |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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