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CAR T-cell Therapy
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
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.
Find a Location
Who is running the clinical trial?
Cartesian TherapeuticsLead Sponsor
8 Previous Clinical Trials
156 Total Patients Enrolled