Study Stopped
Phase 1 enrollment completed. Further clinical development terminated.
Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
2 other identifiers
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Aug 2019
Shorter than P25 for phase_1 multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 21, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedResults Posted
Study results publicly available
April 25, 2025
CompletedMay 15, 2025
April 1, 2025
1.8 years
June 19, 2019
January 21, 2025
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria
Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)
Study Arms (6)
Dose Level 1
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Dose Level 4B
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Interventions
CAR T-Cells
Pre-conditioning chemotherapy
Pre-conditioning therapy
Eligibility Criteria
You may qualify if:
- Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
- measurable disease;
- adequate vital organ function; and
- no active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cartesian Therapeuticslead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Medical College of Wisconsin
Madison, Wisconsin, 53226, United States
Related Publications (7)
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.
PMID: 24777247BACKGROUNDBeatty 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.
PMID: 24579088BACKGROUNDTeachey 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.
PMID: 27076371BACKGROUNDLim 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.
PMID: 28187291BACKGROUNDBrudno 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.
PMID: 27207799BACKGROUNDAli 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.
PMID: 27412889BACKGROUNDGBD 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.
PMID: 25530442BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Vera Sarkodie Medical Director,
- Organization
- Cartesian Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2019
First Posted
June 21, 2019
Study Start
August 1, 2019
Primary Completion
May 27, 2021
Study Completion
June 11, 2021
Last Updated
May 15, 2025
Results First Posted
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share