Descartes-15 for Multiple Myeloma (DC15-MM-01 Trial)

Phase 1

Recruiting

Research Sponsored by Cartesian Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -60 to month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with advanced multiple myeloma. The treatment involves modifying the patient's own immune cells to target a protein called BCMA. The study will assess the safety

Who is the study for?

This trial is for people with Multiple Myeloma that has come back or hasn't responded to treatment. Specific details on who can join are not provided, but typically participants need to meet certain health standards and have a history of the condition being studied.

What is being tested?

The study is testing Descartes-15, an advanced CAR T-cell therapy designed to target BCMA on myeloma cells. It's in Phase I where they start with low doses and gradually increase them to find the safest and most effective dose.

What are the potential side effects?

While specific side effects for Descartes-15 aren't listed, CAR T-cell therapies often cause flu-like symptoms, fatigue, changes in blood pressure, heart rate issues, and could potentially lead to more serious conditions like cytokine release syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -60 to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -60 to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -60 to month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)

Secondary study objectives

To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2 Arm 2 Descartes-15 without lymphodepletionExperimental Treatment1 Intervention

Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy.

Group II: Part 2 Arm 1 Descartes-15 with lymphodepletionExperimental Treatment1 Intervention

Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy.

Group III: Part 1 Descartes-15 with lymphodepletionExperimental Treatment1 Intervention

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.

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