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| Name | Class |
|---|---|
| Peking University Shenzhen Hospital | OTHER |
| Chengdu Military General Hospital | OTHER |
| iCAR Bio Therapeutics Ltd. | INDUSTRY |
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This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.
BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7).
The use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCMA-CD33 cCAR T cells | Experimental | BCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCMA-CS1 cCAR T cells | Biological | BCMA-CS1 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 participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 28 days | |
| Type of dose-limiting toxicity (DLT) | 28 days | |
| Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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 |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Pinz | Contact | 6315386218 | kevin.pinz@icellgene.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongyu Zhang, MD, PhD | Peking University Shenzhen Hospital | Principal Investigator |
| Fang Liu, MD, PhD | Chengdu Military General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Military General Hospital | Recruiting | Chengdu | China |
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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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| 1 year |
| Overall survival | 1 year |
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | 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 |