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NCT03994705 Clinical Trial

Descartes-11 in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03994705
Other study ID # DC11A
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 6, 2019
Est. completion date February 6, 2024

Study information
Verified date February 2023
Source Cartesian Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase I/2 study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date February 6, 2024
Est. primary completion date February 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Active multiple myeloma that is refractory after at least 2 prior lines of therapy; - measurable disease; - adequate vital organ function; and - no active infection.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Descartes-11
CAR T-Cells
Drug:
• Fludarabine
Pre-conditioning chemotherapy
• Cyclophosphamide
Pre-conditioning therapy

Locations
Country Name City State
United States Center for Cancer and Blood Disorders Bethesda Maryland
United States Medical College of Wisconsin Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Cartesian Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence (number) of Treatment-Emergent Adverse Events Safety and Tolerability 14 Days
Secondary Treatment Response IMWG treatment response criteria Time Frame: 1, 3, 6, 9 and 12 months
See also
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1