Descartes-11 in Multiple Myeloma

Phase 1

Terminated

• Conditions: Multiple Myeloma
• Interventions: Biological: Descartes-11; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT03994705
• Lead Sponsor: Cartesian Therapeutics

Brief Summary

This Phase I 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Study Start: 2019-08-01
• Primary Completion: 2021-05-27
• Study Completion: 2021-06-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose-Escalation	Fludarabine	-
Dose-Escalation	Descartes-11	-
Dose-Escalation	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Incidence (number) of Treatment-Emergent Adverse Events	14 Days	Safety and Tolerability

Secondary Outcome Measures

Name	Time	Method
Treatment Response	Time Frame: 1, 3, 6, 9 and 12 months	IMWG treatment response criteria

Trial Locations

Locations (2)

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Medical College of Wisconsin; 🇺🇸 Madison, Wisconsin, United States