Multiple MyelomaPhase 1NCT05113342
Descartes-25 in Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Descartes-25 in people with Multiple Myeloma and Relapse Multiple Myeloma, run by Cartesian Therapeutics at 3 sites in 2 countries.
Trial summary
This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapse Multiple Myeloma
- What is being tested?
- Descartes-25
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Nov 2021to 8 Nov 2024
- 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
- 18 years and older'
- diagnosed with active R/RMM, who have failed 2 lines of treatment
- have measurable disease
Who cannot join
- Patients with active plasma cell leukemia
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Louisiana State University Health Science Center at Shreveport
Shreveport, Louisiana, 71103
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi
Ankara, Anatolia, 06200
About this study
Official title: Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Being tested
- Descartes-25
- Keywords
- myeloma, multiple myeloma, Relapse Refactory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes-25Drug
Also called DC-25
allogeneic Mesenchymal Stem Cell product.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dose Level 1 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. Receives: Drug: Descartes-25 |
| Arm 2: Dose Level 2 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. Receives: Drug: Descartes-25 |
| Arm 3: Dose Level 3 | Experimental | Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. Receives: Drug: Descartes-25 |
| Arm 4: Dose Expansion | Experimental | In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy. Receives: Drug: Descartes-25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start25 Nov 2021
- Primary completion9 May 2023
- Study completion8 Nov 2024
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 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
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05113342
- Sponsor's protocol ID
- DC25-1A
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05113342
- Acronym / sponsor ID
- DC25-1A
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Keywords
- myeloma, multiple myeloma, Relapse Refactory multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1 enrollment completed. Further clinical development terminated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 9 Nov 2021 (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/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose Level 1 | Experimental | Drug: Descartes-25Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
| Arm 2: Dose Level 2 | Experimental | Drug: Descartes-25Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
| Arm 3: Dose Level 3 | Experimental | Drug: Descartes-25Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. |
| Arm 4: Dose Expansion | Experimental | Drug: Descartes-25In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older'
- diagnosed with active R/RMM, who have failed 2 lines of treatment
- have measurable disease
Key exclusion criteria (1 listed)
- Patients with active plasma cell leukemia
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-25Also: DC-25allogeneic Mesenchymal Stem Cell product. | Drug | Arm 1: Dose Level 1, Arm 2: Dose Level 2, Arm 3: Dose Level 3, Arm 4: Dose Expansion |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 Year
Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.
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 12 Nov 2024.
Related trials for Multiple Myeloma
Active, not recruitingObservational study
Agriculture Health Study
Prostate Cancer, Pesticide Exposures
Active, not recruitingPhase 2
Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma
Multiple Myeloma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Active, not recruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
Multiple Myeloma, AL Amyloidosis
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Descartes-25 in people with Multiple Myeloma and Relapse Multiple Myeloma, run by Cartesian Therapeutics at 3 sites in 2 countries.
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 3 inclusion and 1 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Turkey (Türkiye). 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?
Maximum Tolerated Dose (time frame: 1 Year). 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 12 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.