Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Sponsor
Cartesian Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04816526
Collaborator
(none)
30
2
1
39.4
15
0.4
Study Details
Study Description
Brief Summary
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Actual Study Start Date
:
Dec 1, 2021
Anticipated Primary Completion Date
:
Feb 25, 2023
Anticipated Study Completion Date
:
Mar 15, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Descartes 08
|
Biological: Descartes 08
Car T-cells
|
Outcome Measures
Primary Outcome Measures
- Rate of stringent complete response [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must be 18 years of age or older at the time of enrollment
-
High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).
Exclusion Criteria:
-
Patients who are pregnant or lactating.
-
Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California Irvine | Orange | California | United States | 92868 |
| 2 | Sarah Cannon Research Institute at Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
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:
NCT04816526
Other Study ID Numbers:
- DC-08-B
First Posted:
Mar 25, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: