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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA221432-03 | U.S. NIH Grant/Contract | View source |
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Phase 1 enrollment completed. Further clinical development terminated.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 |
|
| Dose Level 2 | Experimental | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 |
|
| Dose Level 3 | Experimental | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 |
|
| Dose Level 4 A | Experimental | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descartes-11 | Biological | CAR T-Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma | Time Frame: 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria | Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG). | Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States | ||
| Medical College of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24777247 | Background | Maus MV, Haas AR, Beatty GL, Albelda SM, Levine BL, Liu X, Zhao Y, Kalos M, June CH. T cells expressing chimeric antigen receptors can cause anaphylaxis in humans. Cancer Immunol Res. 2013 Jul;1(1):26-31. doi: 10.1158/2326-6066.CIR-13-0006. Epub 2013 Apr 7. | |
| 24579088 | Background | Beatty GL, Haas AR, Maus MV, Torigian DA, Soulen MC, Plesa G, Chew A, Zhao Y, Levine BL, Albelda SM, Kalos M, June CH. Mesothelin-specific chimeric antigen receptor mRNA-engineered T cells induce anti-tumor activity in solid malignancies. Cancer Immunol Res. 2014 Feb;2(2):112-20. doi: 10.1158/2326-6066.CIR-13-0170. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decartes-11 Dose Level 1 | Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7, 14 Participants were administered cyclophosphamide and Fludarabine on Days 1,2,3 |
| FG001 | Descates-11 Level 2 | Participants were administered cyclophosphamide and Fludarabine for pre-conitioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7, 14 |
| FG002 | Descartes-11 Dose Level 3 | Participants were administered cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes- 11 on Days 7,14 |
| FG003 | Descartes-11 Dose Level 4A | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7, 14,21 |
| FG004 | Descartes-11 Dose Level 4B | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,17 |
| FG005 | Descartes-11 Dose Level 4C | Participant did not receive preconditioning with cyclophosphamide or fludarabine, Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4,7,10,14,17 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Level 1 Dose | 10 x 10^6 cells / kg |
| BG001 | Level 2 Dose | 32 x 10^6 cells / kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events | Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma | Participants with treatment related adverse event | Posted | Count of Participants | Participants | Time Frame: 21 days |
|
Follow ups conducted on months 3,6,9,12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment | Unrelated to Descartes-11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Gastrointestinal disorders | CTCAE VERSION 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vera Sarkodie Medical Director, | Cartesian Therapeutics | 617-231-8085 | vera.sarkodie@cartesiantx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2020 | Jan 14, 2025 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Dose Level 4B |
| Experimental |
Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 |
|
| Dose Level 4C | Experimental | Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21 |
|
| Fludarabine | Drug | Pre-conditioning chemotherapy |
|
| Cyclophosphamide | Drug | Pre-conditioning therapy |
|
| Madison |
| Wisconsin |
| 53226 |
| United States |
| 27076371 | Background | Teachey DT, Lacey SF, Shaw PA, Melenhorst JJ, Maude SL, Frey N, Pequignot E, Gonzalez VE, Chen F, Finklestein J, Barrett DM, Weiss SL, Fitzgerald JC, Berg RA, Aplenc R, Callahan C, Rheingold SR, Zheng Z, Rose-John S, White JC, Nazimuddin F, Wertheim G, Levine BL, June CH, Porter DL, Grupp SA. Identification of Predictive Biomarkers for Cytokine Release Syndrome after Chimeric Antigen Receptor T-cell Therapy for Acute Lymphoblastic Leukemia. Cancer Discov. 2016 Jun;6(6):664-79. doi: 10.1158/2159-8290.CD-16-0040. Epub 2016 Apr 13. |
| 28187291 | Background | Lim WA, June CH. The Principles of Engineering Immune Cells to Treat Cancer. Cell. 2017 Feb 9;168(4):724-740. doi: 10.1016/j.cell.2017.01.016. |
| 27207799 | Background | Brudno JN, Kochenderfer JN. Toxicities of chimeric antigen receptor T cells: recognition and management. Blood. 2016 Jun 30;127(26):3321-30. doi: 10.1182/blood-2016-04-703751. Epub 2016 May 20. |
| 27412889 | Background | Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13. |
| 25530442 | Background | GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18. |
| BG002 |
| Level 3 Dose |
100 x 10^6 cells / kg |
| BG003 | Level 4A | 150 x 10^6 cells / kg |
| BG004 | Level 4B | 150 x 10^6 cells / kg |
| BG005 | Level 4C | 150 x 10^6 cells / kg |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Dose Level 3 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter |
| OG003 | Dose Level 4A | Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter |
| OG004 | Dose Level 4B | Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter |
| OG005 | Dose Level 4C | Participants were not administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter |
|
|
| Secondary | Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria | Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG). | Posted | Count of Participants | Participants | Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion) |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Level 2 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 | 1 | 4 | 2 | 4 | 2 | 4 |
| EG002 | Dose Level 3 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 | 0 | 3 | 1 | 3 | 2 | 3 |
| EG003 | Dose Level 4A | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 | 0 | 2 | 1 | 2 | 1 | 2 |
| EG004 | Dose Level 4B | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 | 0 | 4 | 1 | 4 | 3 | 4 |
| EG005 | Dose Level 4C | Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21 | 1 | 4 | 0 | 4 | 2 | 4 |
|
| Febrile Neutropenia | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unlikely related to Desartes-11 |
|
| Encephalopathy | Nervous system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Sepsis | Infections and infestations | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Infusion reactions | Infections and infestations | CTCAE VERSION 5.0 | Systematic Assessment | Related to Desartes-11 |
|
| Plasmacytoma | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Dental Infection | Infections and infestations | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Failure to thrive | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Pathologic fractures of right femur and left humerus | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Hypotension | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Hypoxia | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Fever, etiology unknown | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Upper Resipratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Fever (preapheresis) | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment | Unrelated to Desartes-11 |
|
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Granulocyte count decreased | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Neutropenic fever | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Fever (Etiology Unknown) | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Infusion Related Reaction | Immune system disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | Systematic Assessment |
|
Not provided
Not provided
| 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 |