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Phase 1 enrollment completed. Further clinical development terminated.
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This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dose Level 1 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
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| Arm 2: Dose Level 2 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
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| Arm 3: Dose Level 3 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
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| Arm 4: Dose Expansion | Experimental | In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descartes-25 | Drug | allogeneic Mesenchymal Stem Cell product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with active plasma cell leukemia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Science Center at Shreveport | Shreveport | Louisiana | 71103 | United States | ||
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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|
| Center for Cancer and Blood Disorders |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Saglik Bilimleri Universitesi | Ankara | Anatolia | 06200 | Turkey (Türkiye) |
| 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 |