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 |
|---|---|
| iCAR Bio Therapeutics Ltd. | INDUSTRY |
| Peking University Shenzhen Hospital | OTHER |
Not provided
Not provided
Not provided
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.
BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.
BCMA-CD19 cCAR is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing CD19 and plasmacytoid lymphoma cells expressing BCMA. The use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCMA-CD19 cCAR | Experimental | Dose escalation phase: BCMA-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of BCMA and CD19 CARs on a T cell with an escalation approach, 2e6 to 10e6 CAR-T cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCMA-CD19 cCAR T cells | Biological | BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events after BCMA-CD19 cCAR T cells infusion | Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy | 2 years particularly the first 28 days after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| For multiple myeloma - Stringent complete response | Stringent complete response (sCR) (IMWG criteria) | 24 months |
| For multiple myeloma - Complete response (CR) | Complete response (CR) (IMWG criteria) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Pinz, MS | Contact | 6315386218 | kevin.pinz@icellgene.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongyu Zhang, MD/PhD | Peking University Shenzhen Hospital, China | Principal Investigator |
| Fang Liu, MD/PhD | Chengdu Military General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital, China | Recruiting | Shenzhen | Guangdong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Dose escalation phase: BCMA-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of BCMA and CD19 CARs on a T cell with an escalation approach, 2e6 to 10e6 CAR-T cells/kg
Not provided
Not provided
Not provided
Not provided
| 24 months |
| For multiple myeloma - Very good partial response (VGPR) | Very good partial response (VGPR) (IMWG criteria) | 24 months |
| For multiple myeloma - Partial response (PR) | Partial response (PR) (IMWG criteria) | 24 months |
| For multiple myeloma - Minimal response (MR) | Minimal response (MR) (IMWG criteria) | 24 months |
| For multiple myeloma - Stable disease (SD) | Stable disease (SD) (IMWG criteria) | 24 months |
| For multiple myeloma - Progressive disease (PD) | Progressive disease (PD) (IMWG criteria) | 12 months |
| For multiple myeloma - Progression-free survival (PFS) | Progression-free survival (PFS) (IMWG criteria) | up to 24 months |
| For plasmacytoid lymphoma - Assessment of morphologic CR, CR1, no residual disease, and molecular remission | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies | 1 year |
| For plasmacytoid lymphoma - Progression-free survival (PFS) | Progression-free survival (PFS) | 1 year |
| For plasmacytoid lymphoma - Overall survival | Overall survival | 1 year |
| Chengdu Military General Hospital | Recruiting | Chengdu | Sichuan | 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 |
| D008206 | Lymphatic Diseases |