Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

Phase 1

Recruiting

• Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma
• Interventions: Drug: Descartes-15

• Registration Number: NCT06304636
• Lead Sponsor: Cartesian Therapeutics

Brief Summary

This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-12
• Status Verified: 2024-06
• Study Start: 2024-06-19
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-12-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2 Arm 1 Descartes-15 with lymphodepletion	Descartes-15	Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy.
Part 2 Arm 2 Descartes-15 without lymphodepletion	Descartes-15	Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy.
Part 1 Descartes-15 with lymphodepletion	Descartes-15	Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy.

Primary Outcome Measures

Name	Time	Method
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)	Day -60 to Month 12	Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.

Secondary Outcome Measures

Name	Time	Method
To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival	Day 1 to Month 12	Efficacy will be assessed by descriptive statistics of treatment response per IMWG criteria. Efficacy endpoints will be reported as proportion of participants achieving Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and stringent Complete Response (sCR) as the best response at a given dose level and in the overall study population.

Trial Locations

Locations (1)

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