Descartes-25 in Relapsed/Refractory Multiple Myeloma

Cartesian Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Relapse Multiple Myeloma; Multiple Myeloma

Treatments: Drug: Descartes-25

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113342

DC25-1A

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

Arm 1: Dose Level 1

Experimental group

Description:

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.

Treatment:

Drug: Descartes-25

Arm 2: Dose Level 2

Experimental group

Description:

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.

Treatment:

Drug: Descartes-25

Arm 3: Dose Level 3

Experimental group

Description:

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.

Treatment:

Drug: Descartes-25

Arm 4: Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: Descartes-25