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The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.
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This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCARTCS1A | Biological | Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of UCARTCS1A | Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study. | 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Assessment | At Day 35, Day 56 (M2), Day 84 (M3), Follow-up [Q3M up to Month 24; i.e., Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24](streamdown:incomplete-link) | 24 months |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States | ||
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Time Frame: From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24]
| 24 months |
| Progression Free Survival | From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24 | 24 months |
| Overall Survival | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 | 24 months |
| Sarah Cannon Research Institute - Colorado Blood Cancer Institute |
| Denver |
| Colorado |
| 80218 |
| United States |
| Winship Cancer Institute Emory University | Atlanta | Georgia | 30322 | United States |
| Mayo Clinical Cancer Center (MCCC) | Rochester | Minnesota | 55905 | United States |
| Hackensack Meridian Health | Hackensack | New Jersey | 07601 | United States |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | 37203-1625 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Sarah Cannon Research Institute - Methodist Healthcare | San Antonio | Texas | 78229-6306 | 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 |
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