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
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXCR4 modified anti-BCMA CAR T cell therapy | Experimental | CAR T cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXCR4 modified anti-BCMA CAR T cells | Biological | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLT) | Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration | 2 years |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (overall response rate) | Proportion of subjects with the best overall response (BOR) | 3 months,6 months |
| CRR (complete response rate) | Proportion of subjects with the BOR of sCR+CR at Month 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAN LI, Ph.D | Contact | +86(028)85423525 | lidan@wchscu.cn | |
| FUCHUN GUO, MD | Contact | +86(028)85423525 | FCguo0797@wchscu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | 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
| 3 months |
| 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 |