Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

Refractory Multiple Myeloma Clinical Trial

— DC15-MM-01  

Official title:

Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304636
• Other study ID #: DC15-MM-01
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: June 2024
• Source: Cartesian Therapeutics
• Contact: Study Trial Central Mailbox
• Phone: 302-648-6497
• Email: trials[@]cartesiantx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: October 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
United States	Center for Cancer and Blood Disorders (AON)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Cartesian Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)	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.	Day -60 to Month 12
Secondary	To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival	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.	Day 1 to Month 12