Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 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-TaVec200 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVIVO-TaVec200 product | Experimental | Each subject will be given a single-dose LVIVO-TaVec200 product infusion at each dose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIVO-TaVec200 product | Biological | Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1) |
| Pharmacokinetics in peripheral blood | CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec200 infusion | Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1) |
| Pharmacokinetics in bone marrow | CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec200 infusion | Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1) |
| The recommended Phase II dose (RP2D) for this cell | RP2D established through BF-BOIN design and the DLTs occurring following LVIVO-TaVec200 infusion | 30 days after LVIVO-TaVec200 infusion |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijuan Chen | Contact | 025-68306091 | chenljb@126.com | |
| Xuxing Shen | Contact | 025-68306091 | ruxiaoguo1992@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
|
| The Affiliated Hospital of XUZHOU Medical University | Not yet recruiting | Xuzhou | Jiangsu | China |
|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | China |
|
| 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 |