Refractory Multiple MyelomaPhase 1DC15-MM-01NCT06304636
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Descartes-15 in people with Refractory Multiple Myeloma and Relapsed Multiple Myeloma, run by Cartesian Therapeutics at 1 site in United States.
Trial summary
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma, Relapsed Multiple Myeloma
- What is being tested?
- Descartes-15
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 13 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must be 18 years of age or older at the time of enrollment.
- Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
- Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
- Patients must have clinical performance status of ECOG 0-2.
- Patients must have adequate vital organ function as defined by:
- Hemoglobin ≥8 g/dL
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- Absolute neutrophil count > 1000/ mm3
- Platelets > 50,000/mm3
- ALT/AST levels lower than 3-fold of normal
- Creatinine clearance ≥45 mL/min/1.73 m2
- Normal cardiac and pulmonary function
- No thromboembolic events in the past 3 months
- No heparin allergy or active infection
Who cannot join
- Patients who have any active and uncontrolled infection.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
- Patients who have active central nervous system disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Cancer and Blood Disorders (AON)
Bethesda, Maryland, 20817
About this study
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
- Being tested
- Descartes-15
- Keywords
- Relapsed/Refractory, Relapsed Myeloma, Refractory Myeloma, Multiple Myeloma, Car-T, CART, Descartes-15, Descartes, Myeloma, T cells, cell gene
- Medical subject headings
- Multiple Myeloma, Recurrence, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes-15Drug
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Descartes-15 with lymphodepletion | Experimental | Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy. Receives: Drug: Descartes-15 |
| Part 2 Arm 1 Descartes-15 with lymphodepletion | Experimental | Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy. Receives: Drug: Descartes-15 |
| Part 2 Arm 2 Descartes-15 without lymphodepletion | Experimental | Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy. Receives: Drug: Descartes-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.
Measured: Day -60 to Month 12
Secondary outcomes (1)
To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival
Efficacy will be assessed by descriptive statistics of treatment response per IMWG criteria. Efficacy endpoints will be reported as proportion of participants achieving Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and stringent Complete Response (sCR) as the best response at a given dose level and in the overall study population.
Measured: Day 1 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start19 Jun 2024
- Primary completion14 Apr 2025
- Study completion13 Nov 2025
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.
- Other trials for Refractory 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
- Sequential
- Model description
- Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304636
- Sponsor's protocol ID
- DC15-MM-01
- Acronym
- DC15-MM-01
- Status last verified
- Nov 2025
- First submitted
- 28 Feb 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06304636
- Acronym / sponsor ID
- DC15-MM-01 / DC15-MM-01
- Keywords
- Relapsed/Refractory, Relapsed Myeloma, Refractory Myeloma, Multiple Myeloma, Car-T, CART, Descartes-15, Descartes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1 enrollment completed. Further clinical development terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Descartes-15 with lymphodepletion | Experimental | Drug: Descartes-15Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy. |
| Part 2 Arm 1 Descartes-15 with lymphodepletion | Experimental | Drug: Descartes-15Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy. |
| Part 2 Arm 2 Descartes-15 without lymphodepletion | Experimental | Drug: Descartes-15Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must be 18 years of age or older at the time of enrollment.
- Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
- Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
- Patients must have clinical performance status of ECOG 0-2.
- Patients must have adequate vital organ function as defined by:
Key exclusion criteria (3 listed)
- Patients who have any active and uncontrolled infection.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
- Patients who have active central nervous system disease.
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-15Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA | Drug | Part 1 Descartes-15 with lymphodepletion, Part 2 Arm 1 Descartes-15 with lymphodepletion, Part 2 Arm 2 Descartes-15 without lymphodepletion |
Primary outcome
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
Time frame: Day -60 to Month 12
Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.
1 secondary outcome
To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival
Time frame: Day 1 to Month 12
Results and safety
The study was stopped early (reason given: Phase 1 enrollment completed. Further clinical development terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site 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-15 in people with Refractory Multiple Myeloma and Relapsed Multiple Myeloma, run by Cartesian Therapeutics at 1 site 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 13 inclusion and 3 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Phase 1 enrollment completed. Further clinical development terminated). Results are not available in the source record.
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?
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM) (time frame: Day -60 to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.