Descartes-25 in Relapsed/Refractory Multiple Myeloma

NCT ID: NCT05113342

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2024-11-08

Brief Summary

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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

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Conditions

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Multiple Myeloma Relapse Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Dose Level 1

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.

Group Type EXPERIMENTAL

Descartes-25

Intervention Type DRUG

allogeneic Mesenchymal Stem Cell product.

Arm 2: Dose Level 2

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.

Group Type EXPERIMENTAL

Descartes-25

Intervention Type DRUG

allogeneic Mesenchymal Stem Cell product.

Arm 3: Dose Level 3

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.

Group Type EXPERIMENTAL

Descartes-25

Intervention Type DRUG

allogeneic Mesenchymal Stem Cell product.

Arm 4: Dose Expansion

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.

Group Type EXPERIMENTAL

Descartes-25

Intervention Type DRUG

allogeneic Mesenchymal Stem Cell product.

Interventions

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Descartes-25

allogeneic Mesenchymal Stem Cell product.

Intervention Type DRUG

Other Intervention Names

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DC-25

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cartesian Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Louisiana State University Health Science Center at Shreveport

Shreveport, Louisiana, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Saglik Bilimleri Universitesi

Ankara, Anatolia, Turkey (Türkiye)

Site Status

Countries

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United States Turkey (Türkiye)

Other Identifiers

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DC25-1A

Identifier Type: -

Identifier Source: org_study_id

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