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The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide
This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYAD-211 | Experimental | Infusion post preconditioning non-myeloablative chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYAD-211 | Biological | Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Dose Limiting Toxicities | Occurrence of Dose Limiting Toxicities | Up to 36 days post-infusion. |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Nyu Langone Hospitals |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Endoxan |
| Drug |
Preconditioning chemotherapy |
|
|
| Fludara | Drug | Preconditioning chemotherapy |
|
|
| New York |
| New York |
| 10016 |
| United States |
| Universitair Ziekenhuis Antwerpen | Antwerp | 2650 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| AZ DELTA | Roeselare | 8800 | Belgium |
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |