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
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+,CD19+ relapsed or refractory multiple myeloma.
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixed BCMA/CD19 CAR-T Transfer | Experimental | Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous BCMA CAR-T cells and CD19 CAR-T cells | Biological | Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment | 2 year |
| minimal residual disease(MRD) | Assessment of MRD negative overall response rate at 3 months of treatment | 2 year |
| Progression-free survival (PFS) | Assessment of Progression-free survival (PFS) at 6 months of treatment | 2 year |
| Overall survival (OS) | Assessment of overall survival (OS) at 6 months of treatment | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (incidence of adverse events defined as dose-limited toxicity) | Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment. | Study treatment until Week 24 |
| Expression of CD19 CART cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei LI, M.D.;Ph.D. | Contact | +86-139-7003-8386 | yx021021@sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nangchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry. |
| 2 year |
| 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 |