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NCT04816526 Clinical Trial

Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Myeloma Multiple Clinical Trial

Official title:
Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04816526
Other study ID # DC-08-B
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 1, 2021
Est. completion date March 15, 2025

Study information
Verified date April 2022
Source Cartesian Therapeutics
Contact Adam Chowdhury, MD, MBA
Phone 3013488698
Email adam.chowdhury@cartesiantx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date March 15, 2025
Est. primary completion date February 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Descartes 08
Car T-cells

Locations
Country Name City State
United States Sarah Cannon Research Institute at Tennessee Oncology Nashville Tennessee
United States University of California Irvine Orange California

Sponsors (1)
Lead Sponsor Collaborator
Cartesian Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of stringent complete response 2 years
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