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| Name | Class |
|---|---|
| Shanghai Xinpu BioTechnology Company Limited | UNKNOWN |
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The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+/CD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoantigen tumor vaccine monotherapy arm | Experimental | Dose Escalation and Randomization Phase vaccine: 0.2mg, 0.4mg, 1 mg. Dose Expansion Phase vaccine: MTD or 1mg. 3 weeks as a treatment cycle, a total of 9 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized neoantigen tumor vaccine | Biological | Neoantigen tumor vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD) | Day1 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate at the end of treatment | Up to approximately 2 years | |
| Progression-Free Survival (PFS) | Progression-free Survival of Personalized mRNA Tumor Vaccine | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | 64370045 | zwl_trial@163.com | |
| Pengpeng Xu | Contact | 64370045 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | 200020 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Overall Survival (OS) | Overall Survival of Personalized mRNA Tumor Vaccine | Up to approximately 2 years |
| Reaction of antigen-specific T cells in peripheral blood | personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses | Up to 104 weeks |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |