Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Sponsor

Cartesian Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT04436029

Collaborator

(none)

Enrollment

Locations

Arm

20.9

Actual Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.

Condition or Disease	Intervention/Treatment	Phase
Myeloma Multiple	Biological: Descartes 11	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Actual Study Start Date :

Jun 12, 2020

Actual Primary Completion Date :

Mar 10, 2022

Actual Study Completion Date :

Mar 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Descartes 11	Biological: Descartes 11 Car T-cells

Arm

Intervention/Treatment

Experimental: Descartes 11

Biological: Descartes 11

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:

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	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
2	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
3	Stephenson Cancer Center Oklahoma University Health Science Centers	Oklahoma City	Oklahoma	United States	73104
4	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:

NCT04436029

Other Study ID Numbers:

DC 11B

First Posted:

Jun 17, 2020

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 11, 2022