Descartes-25 in Relapsed/Refractory Multiple Myeloma

NCT05113342 | Terminated Phase 1 FDA Drug

• 1 other identifier: DC25-1A
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 3

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.

Conditions

Multiple Myeloma; Relapse Multiple Myeloma

Keywords

myeloma; multiple myeloma; Relapse Refactory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity.

  1 Year

Study Arms (4)

Arm 1: Dose Level 1

EXPERIMENTAL

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.

Drug: Descartes-25

Arm 2: Dose Level 2

EXPERIMENTAL

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.

Drug: Descartes-25

Arm 3: Dose Level 3

EXPERIMENTAL

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.

Drug: Descartes-25

Arm 4: Dose Expansion

EXPERIMENTAL

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.

Drug: Descartes-25

Interventions

Descartes-25 DRUG

allogeneic Mesenchymal Stem Cell product.

Also known as: DC-25

Arm 1: Dose Level 1; Arm 2: Dose Level 2; Arm 3: Dose Level 3; Arm 4: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Patients with active plasma cell leukemia

Sponsors & Collaborators

• Cartesian Therapeutics: lead

Study Sites (3)

Louisiana State University Health Science Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Saglik Bilimleri Universitesi

Ankara, Anatolia, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 9, 2021
• Study Start: November 25, 2021
• Primary Completion: May 9, 2023
• Study Completion: November 8, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1); US (2)