Descartes-25 in Relapsed/Refractory Multiple Myeloma

Phase 1

Terminated

• Conditions: Relapse Multiple Myeloma; Multiple Myeloma
• Interventions: Drug: Descartes-25

• Registration Number: NCT05113342
• Lead Sponsor: Cartesian Therapeutics

Brief Summary

This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Study Start: 2021-11-25
• Primary Completion: 2023-05-09
• Status Verified: 2024-11
• Study Completion: 2024-11-08
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 18 years and older'
• diagnosed with active R/RMM, who have failed 2 lines of treatment
• have measurable disease

Exclusion Criteria

• Patients with active plasma cell leukemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1: Dose Level 1	Descartes-25	Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Arm 2: Dose Level 2	Descartes-25	Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Arm 3: Dose Level 3	Descartes-25	Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached.
Arm 4: Dose Expansion	Descartes-25	In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	1 Year	Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.

Trial Locations

Locations (3)

Louisiana State University Health Science Center at Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Saglik Bilimleri Universitesi; 🇹🇷 Ankara, Anatolia, Turkey

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