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Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

NCT03994705 — Phase 1, Terminated, 20 participants, Cartesian Therapeutics
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Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

RegistryNCT03994705
StatusTerminated - Phase 1 enrollment completed. Further clinical development terminated.
PhasePhase 1
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment20 (Actual)
SponsorCartesian Therapeutics (Industry); collaborators: National Cancer Institute (NCI)
ConditionsMultiple Myeloma
InterventionsDescartes-11, Fludarabine, Cyclophosphamide (Biological, drug)
Datesstart 2019-08-01, primary completion 2021-05-27, completion 2021-06-11, first posted 2019-06-21, last updated 2025-05-15
Locations2 sites in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Dose Level 1ExperimentalBiological: Descartes-11; Drug: Fludarabine; Drug: CyclophosphamideParticipants 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 2ExperimentalBiological: Descartes-11; Drug: Fludarabine; Drug: CyclophosphamideParticipants 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 3ExperimentalBiological: Descartes-11; Drug: Fludarabine; Drug: CyclophosphamideParticipants 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 AExperimentalBiological: Descartes-11; Drug: Fludarabine; Drug: CyclophosphamideParticipants 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 4BExperimentalBiological: Descartes-11; Drug: Fludarabine; Drug: CyclophosphamideParticipants 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 4CExperimentalBiological: Descartes-11Participants 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
  • Descartes-11 (Biological): CAR T-Cells
  • Fludarabine (Drug): Pre-conditioning chemotherapy
  • Cyclophosphamide (Drug): Pre-conditioning therapy

+Outcome measures

Primary outcomes

  • Number of Participants With Treatment-Related Adverse Events [Time Frame: 21 days]: Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma

Secondary outcomes

  • 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)]: Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
* measurable disease;
* adequate vital organ function; and
* no active infection.

+Posted results

Participant flow

MilestoneDecartes-11 Dose Level 1Descates-11 Level 2Descartes-11 Dose Level 3Descartes-11 Dose Level 4ADescartes-11 Dose Level 4BDescartes-11 Dose Level 4C
Started343244
Completed343244
Not completed000000

Outcome results

  • Number of Participants With Treatment-Related Adverse Events (Primary), Count of participants, Participants: Dose-Escalation Level 1 0; Dose Level 2 1; Dose Level 3 1; Dose Level 4A 0; Dose Level 4B 0; Dose Level 4C 0
  • Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria (Secondary), Count of participants, Participants: Dose-Escalation Level 1 0; Dose Level 2 0; Dose Level 3 0; Dose Level 4A 0; Dose Level 4B 0; Dose Level 4C 0

Adverse events

Time frame: Follow ups conducted on months 3,6,9,12.

ArmDeathsSerious adverse eventsOther adverse events
Dose Level 10/3 (0.0%)3/3 (100.0%)3/3 (100.0%)
Dose Level 21/4 (25.0%)2/4 (50.0%)2/4 (50.0%)
Dose Level 30/3 (0.0%)1/3 (33.3%)2/3 (66.7%)
Dose Level 4A0/2 (0.0%)1/2 (50.0%)1/2 (50.0%)
Dose Level 4B0/4 (0.0%)1/4 (25.0%)3/4 (75.0%)
Dose Level 4C1/4 (25.0%)0/4 (0.0%)2/4 (50.0%)

Serious adverse events by term

TermOrgan systemDose Level 1Dose Level 2Dose Level 3Dose Level 4ADose Level 4BDose Level 4C
IleusGastrointestinal disorders0/31/40/30/20/40/4
Febrile NeutropeniaImmune system disorders1/31/41/30/20/40/4
EncephalopathyNervous system disorders0/31/40/30/20/40/4
SepsisInfections and infestations0/31/40/30/20/40/4
Infusion reactionsInfections and infestations0/31/40/30/20/40/4
PlasmacytomaBlood and lymphatic system disorders0/30/41/30/20/40/4
Dental InfectionInfections and infestations0/30/41/30/20/40/4
Acute Kidney InjuryRenal and urinary disorders0/30/40/30/20/40/4
Failure to thriveMetabolism and nutrition disorders0/30/40/30/20/40/4
Generalized weaknessMusculoskeletal and connective tissue disorders2/30/40/30/20/40/4
Pathologic fractures of right femur and left humerusMusculoskeletal and connective tissue disorders0/30/40/30/21/40/4
HypotensionBlood and lymphatic system disorders2/30/40/30/20/40/4
HypoxiaBlood and lymphatic system disorders1/30/40/30/20/40/4
Fever, etiology unknownImmune system disorders1/30/40/30/20/40/4
Neck PainMusculoskeletal and connective tissue disorders0/30/40/31/20/40/4
Upper Resipratory InfectionRespiratory, thoracic and mediastinal disorders1/30/40/30/20/40/4
Fever (preapheresis)Immune system disorders0/31/40/30/20/40/4

Other adverse events by term

TermOrgan systemDose Level 1Dose Level 2Dose Level 3Dose Level 4ADose Level 4BDose Level 4C
Aspartate aminotransferase increasedGastrointestinal disorders2/30/40/30/21/40/4
Chronic Kidney DiseaseRenal and urinary disorders1/30/40/30/20/40/4
FatigueGeneral disorders1/32/40/30/20/40/4
Dyspnea on exertionRespiratory, thoracic and mediastinal disorders1/30/40/30/20/40/4
Granulocyte count decreasedImmune system disorders1/30/40/30/20/40/4
HypoalbuminemiaMetabolism and nutrition disorders1/32/41/30/20/40/4
Back painMusculoskeletal and connective tissue disorders2/31/41/30/20/41/4
AnemiaBlood and lymphatic system disorders3/32/41/31/22/41/4
Neutropenic feverImmune system disorders1/30/41/30/20/40/4
SyncopeNervous system disorders1/30/40/30/20/40/4
Fever (Etiology Unknown)Immune system disorders1/30/40/30/20/40/4
ThrombocytopeniaBlood and lymphatic system disorders1/31/40/30/20/40/4
ConstipationGastrointestinal disorders1/30/40/31/20/40/4
VomitingGastrointestinal disorders0/31/41/30/20/40/4
Infusion Related ReactionImmune system disorders0/32/42/30/20/40/4
HypocalcemiaMetabolism and nutrition disorders1/31/40/30/21/40/4
DysphagiaGastrointestinal disorders1/30/40/31/20/40/4
DehydrationMetabolism and nutrition disorders0/30/41/30/20/40/4
HyperglycemiaMetabolism and nutrition disorders1/30/40/31/21/41/4

+Locations (2)

FacilityCityCountryStatus
Center for Cancer and Blood DisordersBethesda, MarylandUnited States
Medical College of WisconsinMadison, WisconsinUnited States

+Publications

  • 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 24777247
  • 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. PMID 24579088
  • 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. PMID 27076371
  • 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. PMID 28187291
  • 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. PMID 27207799
  • 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. PMID 27412889
  • 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. PMID 25530442

+Study documents

+Funding

NIH grants: R44CA221432

My Notes