Clinical Trials /

Descartes-11 in Multiple Myeloma

NCT03994705

Description:

This Phase I/2 study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03994705

Trial Eligibility

Document

Title

  • Brief Title: Descartes-11 in Multiple Myeloma
  • Official Title: Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: DC11A
  • NCT ID: NCT03994705

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
Descartes-11Dose-Escalation
FludarabineDose-Escalation
CyclophosphamideDose-Escalation

Purpose

This Phase I/2 study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Trial Arms

NameTypeDescriptionInterventions
Dose-EscalationExperimental
  • Descartes-11
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        Inclusion Criteria:

          -  Active multiple myeloma that is refractory after at least 2 prior lines of therapy;

          -  measurable disease;

          -  adequate vital organ function; and

          -  no active infection.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence (number) of Treatment-Emergent Adverse Events
Time Frame:14 Days
Safety Issue:
Description:Safety and Tolerability

Secondary Outcome Measures

Measure:Treatment Response
Time Frame:Time Frame: 1, 3, 6, 9 and 12 months
Safety Issue:
Description:IMWG treatment response criteria

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cartesian Therapeutics

Trial Keywords

  • CAR-T
  • CART
  • CAR T Cell
  • CAR T-Cell
  • Multiple Myeloma
  • BCMA
  • B cell maturation antigen
  • B-cell maturation antigen
  • Descartes-11

Last Updated

February 10, 2021