Descartes-25 in Relapsed/Refractory Multiple Myeloma
Sponsor
Cartesian Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05113342
Collaborator
(none)
20
2
13.2
10
0.8
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date
:
Nov 25, 2021
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Jan 1, 2023
Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose of Descartes-25 [1 Year]
Secondary Outcome Measures
- Overall Response Rate according to the IMWG response criteria [1 Year]
- Median Duration of Response [1 Year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 years and older'
-
diagnosed with active R/RMM, who have failed 2 lines of treatment
-
have measurable disease
Exclusion Criteria:
- Patients with active plasma cell leukemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Cancer and Blood Disorders | Bethesda | Maryland | United States | 20817 |
| 2 | Medical College of Wisconsin | Madison | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Cartesian Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cartesian Therapeutics
ClinicalTrials.gov Identifier:
NCT05113342
Other Study ID Numbers:
- DC25-1A
First Posted:
Nov 9, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cartesian Therapeutics
Additional relevant MeSH terms: