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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.
This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec400 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVIVO-TaVec400 product | Experimental | Each subject will be given a single-dose LVIVO-TaVec400 product infusion at each dose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIVO-TaVec400 product | Biological | Prior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment. | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | |
| Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial. | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) | |
| Pharmacokinetics in peripheral blood | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec400 infusion | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) |
| Pharmacokinetics in bone marrow | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec400 infusion | Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An | Contact | +86 022-23909083 | angang@ihcams.ac.cn | |
| Jianling Yao | Contact | jianling.yao@legendbiotech.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
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| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
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| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
|
| Beijing GoBroad Boren Hospital | Beijing | China |
|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | China |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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