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NCT03994705 · REGISTRY CONDITION SEARCH

Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2025-05-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment-Related Adverse Events

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outcome · POSTED

Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Biological: Descartes-11
    2. Drug: Fludarabine
    3. Drug: Cyclophosphamide
    label
    Dose Level 1
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Biological: Descartes-11
    2. Drug: Fludarabine
    3. Drug: Cyclophosphamide
    label
    Dose Level 2
    type
    EXPERIMENTAL
  3. description
    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
    intervention Names
    1. Biological: Descartes-11
    2. Drug: Fludarabine
    3. Drug: Cyclophosphamide
    label
    Dose Level 3
    type
    EXPERIMENTAL
  4. description
    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
    intervention Names
    1. Biological: Descartes-11
    2. Drug: Fludarabine
    3. Drug: Cyclophosphamide
    label
    Dose Level 4 A
    type
    EXPERIMENTAL
  5. description
    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
    intervention Names
    1. Biological: Descartes-11
    2. Drug: Fludarabine
    3. Drug: Cyclophosphamide
    label
    Dose Level 4B
    type
    EXPERIMENTAL
  6. description
    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
    intervention Names
    1. Biological: Descartes-11
    label
    Dose Level 4C
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Level 1
    2. Dose Level 2
    3. Dose Level 3
    4. Dose Level 4 A
    5. Dose Level 4B
    6. Dose Level 4C
    description
    CAR T-Cells
    name
    Descartes-11
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Dose Level 1
    2. Dose Level 2
    3. Dose Level 3
    4. Dose Level 4 A
    5. Dose Level 4B
    description
    Pre-conditioning chemotherapy
    name
    Fludarabine
    type
    DRUG
  3. arm Group Labels
    1. Dose Level 1
    2. Dose Level 2
    3. Dose Level 3
    4. Dose Level 4 A
    5. Dose Level 4B
    description
    Pre-conditioning therapy
    name
    Cyclophosphamide
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
    measure
    Number of Participants With Treatment-Related Adverse Events
    time Frame
    Time Frame: 21 days
secondary Outcomes
  1. description
    Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).
    measure
    Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria
    time Frame
    Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)
Full study description
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.
Source references
references
  1. citation
    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
    type
    BACKGROUND
  2. citation
    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
    type
    BACKGROUND
  3. citation
    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
    type
    BACKGROUND
  4. citation
    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
    type
    BACKGROUND
  5. citation
    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
    type
    BACKGROUND
  6. citation
    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
    type
    BACKGROUND
  7. citation
    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
    type
    BACKGROUND
Source notices and limitations
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    Preserved source evidence · Not medical advice