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CAR T-cell Therapy

Part 2 Arm 1 Descartes-15 with lymphodepletion 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

DC15-MM-01 Trial 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.Check my eligibility

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.See study design

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.

DC15-MM-01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

DC15-MM-01 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Cartesian TherapeuticsLead Sponsor

8 Previous Clinical Trials

207 Total Patients Enrolled

5 Trials studying Multiple Myeloma

117 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"Indeed, data available on clinicaltrials.gov indicates that this medical research endeavor is actively seeking participants. The trial was first listed on March 1st, 2024, and its most recent update took place on March 8th of the same year. It aims to enroll a total of 41 patients at one designated site."

Answered by AI

Has the initial segment of Descartes-15, combined with lymphodepletion therapy, received official endorsement from the FDA?

"Based on our assessment, the safety rating for Part 1 of Descartes-15 with lymphodepletion is a low score of 1. This reflects the early Phase 1 status where there is minimal data supporting both its safety and effectiveness."

Answered by AI

How many participants in total are involved in this particular research endeavor?

"Indeed, information on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. The study was initially published on March 1st, 2024 and last revised on March 8th, 2024. A total of 41 individuals are sought after from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

2024. "Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06304636.

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