Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

NCT06304636 — Phase 1, Terminated, 4 participants, Cartesian Therapeutics

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT06304636, acronym DC15-MM-01
Status	Terminated - Phase 1 enrollment completed. Further clinical development terminated
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	4 (Actual)
Sponsor	Cartesian Therapeutics (Industry)
Conditions	Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Interventions	Descartes-15 (Drug)
Dates	start 2024-06-19, primary completion 2025-04-14, completion 2025-11-13, first posted 2024-03-12, last updated 2025-11-24
Locations	1 site in United States

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Part 1 Descartes-15 with lymphodepletion	Experimental	Drug: 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.
Part 2 Arm 1 Descartes-15 with lymphodepletion	Experimental	Drug: 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	Experimental	Drug: Descartes-15	Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will not receive lymphodepletion prior to initiating cell therapy.

Descartes-15 (Drug): Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria

* Patients must be 18 years of age or older at the time of enrollment.
* Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
* Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
* Patients must have clinical performance status of ECOG 0-2.
* Patients must have adequate vital organ function as defined by:
* Hemoglobin ≥8 g/dL
* Absolute neutrophil count > 1000/ mm3
* Platelets > 50,000/mm3
* ALT/AST levels lower than 3-fold of normal
* Creatinine clearance ≥45 mL/min/1.73 m2
* Normal cardiac and pulmonary function
* No thromboembolic events in the past 3 months
* No heparin allergy or active infection

Exclusion Criteria

* Patients who have any active and uncontrolled infection.
* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
* Patients who have active central nervous system disease.

+Locations (1)

Facility	City	Country	Status
Center for Cancer and Blood Disorders (AON)	Bethesda, Maryland	United States