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Per sponsor request
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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCAR-BCDR cells product | Experimental | Each subject will receive LCAR-BCDR cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCAR-BCDR cells product | Biological | Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment. | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Recommended Phase 2 dose (RP2D) finding | RP2D established through ATD+BOIN design | 30 days after LCAR-BCDR infusion (Day 1) |
| CAR positive T cells in peripheral blood and bone marrow | CAR positive T cells in peripheral blood and bone marrow after LCAR-BCDR infusion | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| CAR transgene levels in peripheral blood and bone marrow | CAR transgene levels in peripheral blood and bone marrow after LCAR-BCDR infusion | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria. | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gobroad Boren Hospital | Beijing | Beijing Municipality | China | |||
| Zhejiang Provincial People's Hospital |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-BCDR to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first |
| Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Incidence of anti-LCAR-BCDR antibody | Venous blood samples will be collected to measure LCAR-BCDR positive cell concentrations and the transgenic level of LCAR-BCDR, at the time points when anti-LCAR-BCDR antibody serum samples are evaluated | Minimum 2 years after LCAR-BCDR infusion (Day 1) |
| Hangzhou |
| Zhejiang |
| China |
| Shanghai Changzheng Hospital | Shanghai | China |
| Shanghai Fourth People's Hospital Affiliated to Tongji University | Shanghai | China |
| Institute of Hematology & Blood Diseases Hospital | Tianjin | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 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 |