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 Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB-011 | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB-011 | Biological | CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) Number of patients with dose limiting toxicities (DLT) | Number of patients with DLTs during the 28 days following the first administration of CB-011. | 28 days |
| (Part B) Overall Response Rate (ORR) | The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria. | 12 Months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caribou Biosciences | Contact | 510-982-6030 | 3 | clinicaltrials@cariboubio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CU Anschutz Medical Campus, Anshutz Cancer Pavillion | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics | Recruiting | Miami | Florida | 33136 | United States |
|
| University of Kentucky/ Markey Cancer Center | Recruiting | Lexington | Kentucky | 40536 | United States |
|
| Hackensack Meridian John Theurer Cancer Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Duke University Health System (DUHS) | Recruiting | Durham | North Carolina | 27705 | United States |
|
| Oncology Hematology Care, Inc | Recruiting | Cincinnati | Ohio | 45236 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| Huntsman Cancer Institute, University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23235 | United States |
|
| Froedtert and the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided