Multiple MyelomaPhase 1NCT03994705

Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1 study testing Descartes-11, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Cartesian Therapeutics at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Descartes-11, Fludarabine and Cyclophosphamide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 1 Aug 2019to 11 Jun 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Medical College of Wisconsin
Madison, Wisconsin, 53226

Other trials in United States

About this study

Official title: Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Conditions: Multiple Myeloma
Being tested: Descartes-11, Fludarabine, Cyclophosphamide
Keywords: CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen, Descartes-11
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Descartes-11Biological
CAR T-Cells
FludarabineDrug
Pre-conditioning chemotherapy
CyclophosphamideDrug
Pre-conditioning therapy

Study groups in NCT03994705
Study group	Role	What they receive
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 Receives: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide
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 Receives: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide
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 Receives: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide
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 Receives: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide
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 Receives: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide
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 Receives: Biological: Descartes-11

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria
Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).
Measured: Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201911 Jun 2021

First posted21 Jun 2019
Study start1 Aug 2019
Primary completion27 May 2021
Study completion11 Jun 2021

Why it stopped: Phase 1 enrollment completed. Further clinical development terminated.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03994705
Sponsor's protocol ID: DC11A
Other IDs: 5R44CA221432-03
Status last verified: Apr 2025
First submitted: 19 Jun 2019
Last updated: 15 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 25530442

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT03994705
Acronym / sponsor ID: DC11A
Conditions: Multiple Myeloma
Keywords: CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Phase 1 enrollment completed. Further clinical development terminated.
Enrolment: 20 participants (actual)
Lead sponsor: Cartesian TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: National Cancer Institute (NCI)
Study start: 1 Aug 2019 (actual)
Primary completion: 27 May 2021 (actual)
Study completion: 11 Jun 2021 (actual)
First posted: 21 Jun 2019 (actual)
Results: Posted 25 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Dose Level 1	Experimental	Biological: 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 2	Experimental	Biological: 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 3	Experimental	Biological: 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 A	Experimental	Biological: 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 4B	Experimental	Biological: 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 4C	Experimental	Biological: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Descartes-11CAR T-Cells	Biological	Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 A, Dose Level 4B, Dose Level 4C
FludarabinePre-conditioning chemotherapy	Drug	Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 A, Dose Level 4B
CyclophosphamidePre-conditioning therapy	Drug	Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 A, Dose Level 4B

Primary outcome

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

1 secondary outcome

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)

Results and safety

Results posted to the registry on 25 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decartes-11 Dose Level 1	3	3
Descates-11 Level 2	4	4
Descartes-11 Dose Level 3	3	3
Descartes-11 Dose Level 4A	2	2
Descartes-11 Dose Level 4B	4	4
Descartes-11 Dose Level 4C	4	4

Primary outcome: Number of Participants With Treatment-Related Adverse Events

Time frame: Time Frame: 21 days. Count of participants. Unit: Participants

Measure	Dose-Escalation Level 1 n = 3	Dose Level 2 n = 4	Dose Level 3 n = 3	Dose Level 4A n = 2	Dose Level 4B n = 4	Dose Level 4C n = 4
Value	0	1	1	0	0	0

Population analysed: Participants with treatment related adverse event

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Follow ups conducted on months 3,6,9,12.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1	3 of 3 (100%)	3 of 3 (100%)	0 of 3
Dose Level 2	2 of 4 (50%)	2 of 4 (50%)	1 of 4
Dose Level 3	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Dose Level 4A	1 of 2 (50%)	1 of 2 (50%)	0 of 2
Dose Level 4B	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Dose Level 4C	0 of 4 (0%)	2 of 4 (50%)	1 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24777247Maus 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.
Background: PubMed 24579088Beatty 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.
Background: PubMed 27076371Teachey 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.
Background: PubMed 28187291Lim 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.
Background: PubMed 27207799Brudno 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.
Background: PubMed 27412889Ali 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.
Background: PubMed 25530442GBD 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.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
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Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Descartes-11, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Cartesian Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events (time frame: Time Frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994705, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.